Trial Outcomes & Findings for Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopharyngeal Cancer (NCT NCT00057785)

Last Updated: 2017-02-17

Results Overview

Patients scored by the study chairs as no variation or minor variation were considered compliant, while patients scored as major variation or inevaluable were considered non-compliant. The number being reported is the number non-compliant. A compliance rate of 90% was targeted with 75% or lower being considered unacceptable. Fifty-seven patients were required with types I and II error rates both 0.10. If 10 or more patients out of 57 were non-compliant, the treatment would be unacceptable, per a two-stage Fleming multiple testing procedure.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

68 participants

Primary outcome timeframe

From start of treatment to end of treatment

Results posted on

2017-02-17

Participant Flow

Participant milestones

Participant milestones
Measure	IMRT +/- Chemotherapy Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
Overall Study STARTED	68
Overall Study COMPLETED	68
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopharyngeal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IMRT +/- Chemotherapy n=68 Participants Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
Age, Continuous	48.5 years n=39 Participants
Gender Female	17 Participants n=39 Participants
Gender Male	51 Participants n=39 Participants

PRIMARY outcome

Timeframe: From start of treatment to end of treatment

Population: First 57 eligible patients who started study treatment.

Outcome measures

Outcome measures
Measure	IMRT +/- Chemotherapy n=57 Participants Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
Protocol Compliance of Intensity-modulated Radiotherapy Treatment Delivered	9 participants

SECONDARY outcome

Timeframe: From start of treatment to 1 year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From registration to 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of treatment to 1 year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of treatment to last follow-up

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of treatment to end of treatment

Outcome measures

Outcome data not reported

Adverse Events

IMRT +/- Chemotherapy

Serious events: 55 serious events

Other events: 68 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	IMRT +/- Chemotherapy n=68 participants at risk Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
Blood and lymphatic system disorders Febrile neutropenia	4.4% 3/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Blood and lymphatic system disorders Hemoglobin decreased	14.7% 10/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Blood and lymphatic system disorders Packed red blood cell transfusion	5.9% 4/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Cardiac disorders Edema NOS	1.5% 1/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Cardiac disorders Left ventricular failure	1.5% 1/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Cardiac disorders Sinus tachycardia	1.5% 1/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Cardiac disorders Supraventricular arrhythmia NOS	1.5% 1/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Cardiac disorders Ventricular arrhythmia NOS	1.5% 1/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Ear and labyrinth disorders Hearing impaired	11.8% 8/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Ear and labyrinth disorders Hearing-Other	4.4% 3/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Ear and labyrinth disorders Otitis externa (exc boil of meatus) NOS	2.9% 2/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Endocrine disorders Endocrine-Other	2.9% 2/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Endocrine disorders Hypothyroidism	1.5% 1/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Gastrointestinal disorders Diarrhea NOS	1.5% 1/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Gastrointestinal disorders Dry mouth	4.4% 3/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Gastrointestinal disorders Dysphagia	23.5% 16/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Gastrointestinal disorders Esophageal spasm	8.8% 6/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Gastrointestinal disorders Esophagitis NOS	19.1% 13/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Gastrointestinal disorders Nausea	30.9% 21/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Gastrointestinal disorders Radiation mucositis	41.2% 28/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Gastrointestinal disorders Salivary gland disorder NOS	1.5% 1/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Gastrointestinal disorders Stomatitis	8.8% 6/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Gastrointestinal disorders Vomiting NOS	27.9% 19/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
General disorders Fatigue	8.8% 6/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
General disorders Pain due to radiation	8.8% 6/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
General disorders Pain-other	8.8% 6/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
General disorders Pyrexia	1.5% 1/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Infections and infestations Implant infection	1.5% 1/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Infections and infestations Infection NOS	4.4% 3/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Infections and infestations Infection with grade 3 or 4 neutropenia	5.9% 4/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Infections and infestations Infection with unknown ANC	1.5% 1/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Infections and infestations Infection, Other	2.9% 2/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Injury, poisoning and procedural complications Dermatitis radiation NOS	8.8% 6/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Investigations Alanine aminotransferase increased	1.5% 1/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Investigations Aspartate aminotransferase increased	1.5% 1/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Investigations Blood creatinine increased	1.5% 1/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Investigations CD4 lymphocytes decreased	1.5% 1/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Investigations Inappropriate ADH secretion	1.5% 1/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Investigations Leukocytes for BMT	1.5% 1/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Investigations Leukopenia NOS	5.9% 4/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Investigations Lymphopenia	16.2% 11/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Investigations Neutropenia	29.4% 20/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Investigations Platelet count decreased	5.9% 4/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Investigations Weight decreased	17.6% 12/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Investigations Weight increased	1.5% 1/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Metabolism and nutrition disorders Acidosis NOS	1.5% 1/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Metabolism and nutrition disorders Anorexia	10.3% 7/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Metabolism and nutrition disorders Blood albumin decreased	2.9% 2/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Metabolism and nutrition disorders Blood magnesium decreased	2.9% 2/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Metabolism and nutrition disorders Dehydration	16.2% 11/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Metabolism and nutrition disorders Hyperglycemia NOS	5.9% 4/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Metabolism and nutrition disorders Hyperkalemia	1.5% 1/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Metabolism and nutrition disorders Hypocalcemia	7.4% 5/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Metabolism and nutrition disorders Hypokalemia	11.8% 8/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Metabolism and nutrition disorders Hyponatremia	17.6% 12/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Metabolism and nutrition disorders Hypophosphatemia	2.9% 2/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Musculoskeletal and connective tissue disorders Joint, muscle, or bone-Other	1.5% 1/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	1.5% 1/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Nervous system disorders Headache NOS	1.5% 1/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Nervous system disorders Neurologic-Other	1.5% 1/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Nervous system disorders Peripheral motor neuropathy	1.5% 1/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Nervous system disorders Peripheral sensory neuropathy	1.5% 1/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Nervous system disorders Syncope	4.4% 3/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Psychiatric disorders Anxiety NEC	1.5% 1/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Psychiatric disorders Depression NEC	1.5% 1/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Psychiatric disorders Hallucination NOS	2.9% 2/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Renal and urinary disorders Renal failure NOS	1.5% 1/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Renal and urinary disorders Renal/GU-Other	2.9% 2/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Respiratory, thoracic and mediastinal disorders Dyspnea NOS	1.5% 1/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Respiratory, thoracic and mediastinal disorders Hypoxia	4.4% 3/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Respiratory, thoracic and mediastinal disorders Pneumonitis NOS	4.4% 3/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Respiratory, thoracic and mediastinal disorders Pulmonary-other	1.5% 1/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Skin and subcutaneous tissue disorders Erythema multiforme	1.5% 1/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Skin and subcutaneous tissue disorders Skin-Other	2.9% 2/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Vascular disorders Hemorrhage NOS	1.5% 1/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Vascular disorders Hypotension NOS	8.8% 6/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Vascular disorders Thrombosis NOS	1.5% 1/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).

Other adverse events

Other adverse events
Measure	IMRT +/- Chemotherapy n=68 participants at risk Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
Nervous system disorders Peripheral motor neuropathy	8.8% 6/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Nervous system disorders Peripheral sensory neuropathy	33.8% 23/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Nervous system disorders Taste disturbance	27.9% 19/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Psychiatric disorders Confusion	5.9% 4/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Psychiatric disorders Insomnia NEC	5.9% 4/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Renal and urinary disorders Renal/GU-Other	19.1% 13/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Respiratory, thoracic and mediastinal disorders Cough	16.2% 11/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Respiratory, thoracic and mediastinal disorders Dysphonia	7.4% 5/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Respiratory, thoracic and mediastinal disorders Dyspnea NOS	8.8% 6/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Respiratory, thoracic and mediastinal disorders Epistaxis	22.1% 15/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Respiratory, thoracic and mediastinal disorders Hiccups	7.4% 5/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Respiratory, thoracic and mediastinal disorders Pulmonary-other	5.9% 4/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Respiratory, thoracic and mediastinal disorders Rhinitis allergic NOS	7.4% 5/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Skin and subcutaneous tissue disorders Alopecia	29.4% 20/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Skin and subcutaneous tissue disorders Dermatitis exfoliative NOS	8.8% 6/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Skin and subcutaneous tissue disorders Erythema multiforme	8.8% 6/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Skin and subcutaneous tissue disorders Skin discoloration	13.2% 9/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Skin and subcutaneous tissue disorders Skin-Other	11.8% 8/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Skin and subcutaneous tissue disorders Toxicoderma	5.9% 4/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Blood and lymphatic system disorders Hematologic-Other	11.8% 8/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Blood and lymphatic system disorders Hemoglobin decreased	75.0% 51/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Cardiac disorders Edema NOS	19.1% 13/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Ear and labyrinth disorders Earache	5.9% 4/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Ear and labyrinth disorders Hearing impaired	48.5% 33/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Ear and labyrinth disorders Hearing-Other	25.0% 17/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Ear and labyrinth disorders Late RT toxicity: Auditory/hearing: NOS	47.1% 32/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Ear and labyrinth disorders Otitis media serous NOS	10.3% 7/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Endocrine disorders Hypothyroidism	14.7% 10/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Gastrointestinal disorders Constipation	20.6% 14/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Gastrointestinal disorders Diarrhea NOS	13.2% 9/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Gastrointestinal disorders Dry mouth	89.7% 61/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Gastrointestinal disorders Dysphagia	35.3% 24/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Gastrointestinal disorders Esophagitis NOS	41.2% 28/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Gastrointestinal disorders GI-other	11.8% 8/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Gastrointestinal disorders Late RT toxicity: Esophagus: NOS	41.2% 28/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Gastrointestinal disorders Late RT toxicity: Larynx: NOS	19.1% 13/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Gastrointestinal disorders Late RT toxicity: Mucous membrane: NOS	60.3% 41/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Gastrointestinal disorders Late RT toxicity: Salivary gland: NOS	75.0% 51/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Gastrointestinal disorders Nausea	67.6% 46/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Gastrointestinal disorders Radiation mucositis	73.5% 50/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Gastrointestinal disorders Salivary gland disorder NOS	86.8% 59/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Gastrointestinal disorders Stomatitis	22.1% 15/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Gastrointestinal disorders Vomiting NOS	45.6% 31/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
General disorders Fatigue	73.5% 50/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
General disorders Late RT toxicity: Other: NOS	48.5% 33/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
General disorders Pain due to radiation	35.3% 24/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
General disorders Pain-other	35.3% 24/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
General disorders Pyrexia	14.7% 10/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
General disorders Rigors	7.4% 5/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Infections and infestations Infection NOS	10.3% 7/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Injury, poisoning and procedural complications Dermatitis radiation NOS	63.2% 43/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Injury, poisoning and procedural complications Late RT toxicity: Skin (within RT field): NOS	32.4% 22/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Injury, poisoning and procedural complications Late RT toxicity: Subcutaneous tissue (within RT field): NOS	39.7% 27/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Investigations Alanine aminotransferase increased	19.1% 13/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Investigations Aspartate aminotransferase increased	13.2% 9/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Investigations Blood alkaline phosphatase NOS increased	13.2% 9/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Investigations Blood bilirubin increased	8.8% 6/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Investigations Blood creatinine increased	17.6% 12/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Investigations Gamma-glutamyltransferase increased	7.4% 5/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Investigations Leukopenia NOS	73.5% 50/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Investigations Lymphopenia	23.5% 16/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Investigations Metabolic-Other	10.3% 7/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Investigations Neutropenia	48.5% 33/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Investigations Platelet count decreased	26.5% 18/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Investigations Weight decreased	58.8% 40/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Metabolism and nutrition disorders Anorexia	26.5% 18/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Metabolism and nutrition disorders Blood albumin decreased	27.9% 19/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Metabolism and nutrition disorders Blood magnesium decreased	22.1% 15/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Metabolism and nutrition disorders Dehydration	27.9% 19/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Metabolism and nutrition disorders Hyperglycemia NOS	23.5% 16/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Metabolism and nutrition disorders Hyperkalemia	10.3% 7/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Metabolism and nutrition disorders Hypocalcemia	25.0% 17/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Metabolism and nutrition disorders Hypokalemia	22.1% 15/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Metabolism and nutrition disorders Hyponatremia	38.2% 26/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Metabolism and nutrition disorders Hypophosphatemia	8.8% 6/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Musculoskeletal and connective tissue disorders Joint, muscle, or bone-Other	5.9% 4/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Musculoskeletal and connective tissue disorders Late RT toxicity: Bone (incl. osteonecrosis): NOS	5.9% 4/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Musculoskeletal and connective tissue disorders Late RT toxicity: Joint: NOS	19.1% 13/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Nervous system disorders Dizziness (exc vertigo)	5.9% 4/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Nervous system disorders Headache NOS	14.7% 10/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).
Nervous system disorders Neuralgia NOS	5.9% 4/68 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for nonserious adverse events (AE).

Additional Information

Wendy Seiferheld

NRG Oncology

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
Publication restrictions are in place

Restriction type: OTHER