Trial Outcomes & Findings for Proton Radiation Therapy (RT) for the Treatment of Pediatric Rhabdomyosarcoma (NCT NCT00592592)

Last Updated: 2025-06-18

Results Overview

Cumulative incidence of participants who experienced a toxicity defined as either grade 3, 4, or 5 after the completion of radiation therapy in pediatric patients with pediatric rhabdomyosarcomas. Late toxicity is scored on a yearly follow-up basis for at least five years. Late toxicities will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. Cumulative incidence is shown at 5 years follow-up.

Recruitment status

COMPLETED

Study phase

Target enrollment

115 participants

Primary outcome timeframe

5 years from the start of radiation treatment

Results posted on

2025-06-18

Participant Flow

Participant milestones

Participant milestones
Measure	Proton Beam Radiation Proton Beam Radiation Proton Beam Radiation: Once per day, 5 days a week for a total of 4 to 6 weeks.
Overall Study STARTED	115
Overall Study COMPLETED	114
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Proton Beam Radiation Proton Beam Radiation Proton Beam Radiation: Once per day, 5 days a week for a total of 4 to 6 weeks.
Overall Study Patient found ineligible upon chart review	1

Baseline Characteristics

Proton Radiation Therapy (RT) for the Treatment of Pediatric Rhabdomyosarcoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Proton Beam Radiation n=114 Participants Proton Beam Radiation Proton Beam Radiation: Once per day, 5 days a week for a total of 4 to 6 weeks.
Age, Continuous	4.3 years n=99 Participants
Sex: Female, Male Female	51 Participants n=99 Participants
Sex: Female, Male Male	63 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	2 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	7 Participants n=99 Participants
Race (NIH/OMB) White	86 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	19 Participants n=99 Participants
Region of Enrollment United States	114 participants n=99 Participants

PRIMARY outcome

Timeframe: 5 years from the start of radiation treatment

Outcome measures

Outcome measures
Measure	Proton Beam Radiation n=114 Participants Proton Beam Radiation Proton Beam Radiation: Once per day, 5 days a week for a total of 4 to 6 weeks.
Cumulative Incidence (Estimated Percent of Participants) With Grade 3 or Higher Toxicity in Follow-up	10.9 Percentage of patients Interval 5.7 to 18.0

SECONDARY outcome

Timeframe: 3 months from radiation treatment

Percentage of participants who experienced an acute toxicity following completion of radiation treatment by grade. Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. The recommended evaluation time for acute toxicity after radiotherapy was 6 weeks following completion, but may be at any time during the 3 months after treatment. Acute toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. Toxicities are graded on a scale of 1 to 5. A higher grade indicates a worse outcome with 1 being mild, 4 being life-threatening, and 5 being death.

Outcome measures

Outcome measures
Measure	Proton Beam Radiation n=114 Participants Proton Beam Radiation Proton Beam Radiation: Once per day, 5 days a week for a total of 4 to 6 weeks.
Percentage of Participants Who Experienced an Acute Toxicity by Grade Grade 1	110 Participants
Percentage of Participants Who Experienced an Acute Toxicity by Grade Grade 2	92 Participants
Percentage of Participants Who Experienced an Acute Toxicity by Grade Grade 3	30 Participants
Percentage of Participants Who Experienced an Acute Toxicity by Grade Grade 4	5 Participants
Percentage of Participants Who Experienced an Acute Toxicity by Grade Grade 5	0 Participants

SECONDARY outcome

Timeframe: 4 years from the start of radiation treatment

Population: Patients who had DVH's generated from proton plans for comparison

Comparison of dose distribution to tumor and surrounding normal structures using dose volume histograms (DVH) generated from the proton plan used to treat the patient and the photon plan generated for comparison purposes. Percent of normal tissue spared was calculated using the following equation: (100 x (mean x-ray dose - mean proton dose))/mean X-ray dose. No measure of dispersion was calculated for these estimates. The data is no longer available.

Outcome measures

Outcome measures
Measure	Proton Beam Radiation n=54 Participants Proton Beam Radiation Proton Beam Radiation: Once per day, 5 days a week for a total of 4 to 6 weeks.
Dosimetric Comparison Hypothalamus	88 Percentage of normal tissue spared of RT
Dosimetric Comparison Pituitary	73 Percentage of normal tissue spared of RT
Dosimetric Comparison Lens (Contra)	100 Percentage of normal tissue spared of RT
Dosimetric Comparison Maxilla	42 Percentage of normal tissue spared of RT

SECONDARY outcome

Timeframe: 5 years from the start of radiation therapy

Estimated survival probability (defined as being free of a local recurrence) was calculated using Grays formula for competing risks

Outcome measures

Outcome measures
Measure	Proton Beam Radiation n=114 Participants Proton Beam Radiation Proton Beam Radiation: Once per day, 5 days a week for a total of 4 to 6 weeks.
Local Control	80.9 percent probability Interval 73.0 to 87.7

Adverse Events

Proton Beam Radiation

Serious events: 6 serious events

Other events: 113 other events

Deaths: 28 deaths

Serious adverse events

Serious adverse events
Measure	Proton Beam Radiation n=114 participants at risk Proton Beam Radiation Proton Beam Radiation: Once per day, 5 days a week for a total of 4 to 6 weeks.
Eye disorders Right eye blindness	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders Abdominal pain	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Psychiatric disorders Mood alteration- Depression	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Infections and infestations Infection- Other (Thrush)	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Infections and infestations Infection- Other (C Diff)	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Blood and lymphatic system disorders Febrile Neutropenia	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Metabolism and nutrition disorders Dehydration	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.

Other adverse events

Other adverse events
Measure	Proton Beam Radiation n=114 participants at risk Proton Beam Radiation Proton Beam Radiation: Once per day, 5 days a week for a total of 4 to 6 weeks.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	7.9% 9/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Ear and labyrinth disorders Hearing w/w-o audiogr in monitor prg	9.6% 11/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Ear and labyrinth disorders Hearing-other	7.9% 9/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Ear and labyrinth disorders Otitis, middle ear (non-infectious)	6.1% 7/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Ear and labyrinth disorders Otitis, external ear (non-infectious)	2.6% 3/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Ear and labyrinth disorders Hearing w/o audiogr not in monitor prg	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Investigations Hemoglobin	7.0% 8/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Investigations Neutrophils	7.0% 8/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Investigations Leukocytes	5.3% 6/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Blood and lymphatic system disorders Lymphopenia	3.5% 4/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Blood and lymphatic system disorders Hematologic-other	3.5% 4/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Investigations Platelets	2.6% 3/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
General disorders Fatigue	57.9% 66/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Metabolism and nutrition disorders Weight loss	7.9% 9/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
General disorders Constitutional, other	1.8% 2/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
General disorders Fever w/o neutropenia	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
General disorders Odor (patient odor)	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Injury, poisoning and procedural complications Radiation dermatitis	78.1% 89/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Skin and subcutaneous tissue disorders Hyperpigmentation	36.8% 42/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Skin and subcutaneous tissue disorders Erythema multiforme	18.4% 21/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Skin and subcutaneous tissue disorders Skin-other	17.5% 20/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Skin and subcutaneous tissue disorders Alopecia	4.4% 5/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Skin and subcutaneous tissue disorders Pruritus/itching	3.5% 4/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Skin and subcutaneous tissue disorders Atrophy, Subcutaneous fat	1.8% 2/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Skin and subcutaneous tissue disorders Dry skin	1.8% 2/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Skin and subcutaneous tissue disorders Hypopigmentation	1.8% 2/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Skin and subcutaneous tissue disorders Induration/fibrosis	1.8% 2/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Skin and subcutaneous tissue disorders Athropy, skin	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Skin and subcutaneous tissue disorders Bruising	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Skin and subcutaneous tissue disorders Injection site reaction	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Skin and subcutaneous tissue disorders Photosensitivity	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Injury, poisoning and procedural complications Chemoradiation dermatitis	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Skin and subcutaneous tissue disorders Telangiectasia	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Skin and subcutaneous tissue disorders Ulceration	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Endocrine disorders Growth hormone secretion abnormality	9.6% 11/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Endocrine disorders Hypothyroidism	7.9% 9/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Endocrine disorders Endocrine-other	4.4% 5/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Endocrine disorders Adrenal insufficiency	2.6% 3/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Endocrine disorders Gonadotropin secretion abnormality	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Metabolism and nutrition disorders Anorexia	35.1% 40/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders Muco/stomatitis by exam, oral cavity	35.1% 40/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders Nausea	22.8% 26/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders Vomiting	14.9% 17/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders Taste disturbance	11.4% 13/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders Diarrhea w/o prior colostomy	10.5% 12/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders Teeth	9.6% 11/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders Teeth development	9.6% 11/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders Dysphagia	8.8% 10/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders Muco/stomatitis (symptom) oral cavity	8.8% 10/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders Dry mouth	7.9% 9/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders GI-other	6.1% 7/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders Dehydration	4.4% 5/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders Constipation	2.6% 3/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders Muco/stomatitis by exam, pharynx	2.6% 3/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders Salivary	2.6% 3/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders Flatulence	1.8% 2/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders Esophagitis	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders Fistula, Oral Cavity	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders Incontinence, anal	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders Muco/stomatitis by exam, rectum	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders Ulcer, anus	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Endocrine disorders Growth velocity reduction	7.9% 9/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders Short stature	3.5% 4/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders Limb length discrepancy	2.6% 3/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Endocrine disorders Puberty, precocious	1.8% 2/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders Alteration in bone age	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders Spine kyphosis/lordosis	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders Nose, hemorrhage	9.6% 11/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
General disorders Hemorrhage-other	2.6% 3/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders Anus, hemorrhage	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders Rectum, hemorrhage	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Skin and subcutaneous tissue disorders Petechiae	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Infections and infestations Infection-other	28.1% 32/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Infections and infestations Infection w/ unk ANC conjunctiva	1.8% 2/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Infections and infestations Infection w/ unk ANC oral cavity/gums	1.8% 2/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Infections and infestations Infection w/ unk ANC sinus	1.8% 2/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Infections and infestations Infection Gr0-2 neut, conjunctiva	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Infections and infestations Infection Gr0-2 neut, sinus	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Blood and lymphatic system disorders Edema head and neck	14.9% 17/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Blood and lymphatic system disorders Lymphatics-other	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Blood and lymphatic system disorders Edema limb	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders Muscular/skeletal hypoplasia	31.6% 36/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders Trismus	6.1% 7/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders Musculoskeletal/soft tissue-other	6.1% 7/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders Joint-function	2.6% 3/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders Bone: spine-scoliosis	1.8% 2/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders Nonneuropathic lower extr muscle weak	1.8% 2/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders Nonneuropathic facial muscle weak	1.8% 2/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders Nonneuropathic generalized weakness	1.8% 2/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders Extremity-lower (gait/walking)	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Nervous system disorders Cognitive disturbance	11.4% 13/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Psychiatric disorders Anxiety	9.6% 11/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Psychiatric disorders Irritability (children < 3yrs of age)	3.5% 4/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Nervous system disorders Dizziness	1.8% 2/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Nervous system disorders Memory impairment	1.8% 2/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Nervous system disorders Neuropathy CN III pupil/eyelid/extraocul	1.8% 2/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Nervous system disorders Neurologic-other	1.8% 2/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Nervous system disorders Neuropathy CN VII face-motor / taste	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Nervous system disorders Neuropathy CN IX pharynx ear tongue	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Nervous system disorders Neuropathy-sensory	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Nervous system disorders Speech impairment	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Eye disorders Ocular-other	33.3% 38/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Eye disorders Cataract	19.3% 22/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Eye disorders Dry eye syndrome	14.0% 16/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Eye disorders Tearing	8.8% 10/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Eye disorders Vision-blurred	7.9% 9/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Eye disorders Ocular surface disease	5.3% 6/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Eye disorders Eyelid dysfunction	4.4% 5/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Eye disorders Proptosis/enophthalmos	4.4% 5/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Eye disorders Keratitis	3.5% 4/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Eye disorders Vision-photophobia	3.5% 4/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Eye disorders Nystagmus	1.8% 2/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Eye disorders Double vision	1.8% 2/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Eye disorders Retinopathy	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Eye disorders Scleral necrosis/melt	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders Nasal cavity/paranasal sinus reaction	18.4% 21/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory-other	9.6% 11/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders Cough	5.3% 6/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders Voice changes/dysarthria	4.4% 5/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Renal and urinary disorders Urinary frequency/urgency	4.4% 5/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Renal and urinary disorders Incontinence urinary	2.6% 3/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Renal and urinary disorders Urinary retention	2.6% 3/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Renal and urinary disorders Renal/GU-other	1.8% 2/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Renal and urinary disorders Cystitis	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Reproductive system and breast disorders Sexual/Reproductive function-Other	1.8% 2/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Vascular disorders Vascular-Other (Specify)	1.8% 2/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Vascular disorders Vessel injury Carotid	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders Throat/pharynx/larynx, pain	13.2% 15/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders Oral cavity, pain	12.3% 14/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
General disorders Pain-other	7.9% 9/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Eye disorders Eye, pain	6.1% 7/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Nervous system disorders Head/headache	6.1% 7/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
General disorders Face, pain	4.4% 5/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders Extremity-limb, pain	2.6% 3/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Ear and labyrinth disorders Middle ear, pain	2.6% 3/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders Abdomen, pain	1.8% 2/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders Back, pain	1.8% 2/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders Neck, pain	1.8% 2/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders Oral gums, pain	1.8% 2/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders Rectum, pain	1.8% 2/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders Anus, pain	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders Buttock, pain	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders Esophagus, pain	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Ear and labyrinth disorders External ear, pain	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Hepatobiliary disorders Liver, pain	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders Muscle, pain	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Reproductive system and breast disorders Ovulatory, pain	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Reproductive system and breast disorders Pelvic, pain	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
General disorders Pain NOS	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Renal and urinary disorders Urethra, pain	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Reproductive system and breast disorders Vagina, pain	0.88% 1/114 • All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for at least 5 years from the start of radiation treatment. Acute toxicity was scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity was scored at least one time within the 3 months following completion of radiation therapy. Late toxicity were scored on a yearly follow-up basis for at least five years. Adverse events were monitored through study completion. Toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.

Additional Information

Torunn Yock, MD

Massachusetts General, Hospital

Phone: 6177262000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place