Trial Outcomes & Findings for Intensity-Modulated Radiation Therapy, Fluorouracil, and Mitomycin C in Treating Patients With Invasive Anal Cancer (NCT NCT00423293)

Last Updated: 2019-02-27

Results Overview

Highest grade adverse event per subject were counted. Adverse events were graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Acute toxicities occur within 90 days of the start of treatment.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

63 participants

Primary outcome timeframe

From the start of treatment to 90 days

Results posted on

2019-02-27

Participant Flow

Participant milestones

Participant milestones
Measure	5-FU + Mitomycin + IMRT 5-FU + Mitomycin + IMRT
Overall Study STARTED	63
Overall Study COMPLETED	52
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	5-FU + Mitomycin + IMRT 5-FU + Mitomycin + IMRT
Overall Study Ineligible / No protocol treatment	11

Baseline Characteristics

Intensity-Modulated Radiation Therapy, Fluorouracil, and Mitomycin C in Treating Patients With Invasive Anal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	5-FU + Mitomycin + IMRT n=52 Participants 5-FU + Mitomycin + IMRT
Age, Continuous	58 years n=99 Participants
Sex: Female, Male Female	42 Participants n=99 Participants
Sex: Female, Male Male	10 Participants n=99 Participants

PRIMARY outcome

Timeframe: From the start of treatment to 90 days

Population: Eligible patients with adverse event information.

Outcome measures

Outcome measures
Measure	5-FU + Mitomycin + IMRT n=52 Participants 5-FU + Mitomycin + IMRT
Percentage of Subjects With Acute Gastrointestinal (GI) and Genitourinary (GU) Adverse Events (AE) ≥ Grade 2 as Defined by CTCAE v3.0 (Common Terminology Criteria for Adverse Events)	77 percentage of participants Interval to 87.0 This is a one-sided confidence interval.

SECONDARY outcome

Timeframe: Planning occurred prior to radiation therapy

Population: All eligible patients who started IMRT

Deviations in intensity-modulated radiation therapy technique (IMRT) planning were determined by central review by the radiation oncology co-chairs of the study.

Outcome measures

Outcome measures
Measure	5-FU + Mitomycin + IMRT n=51 Participants 5-FU + Mitomycin + IMRT
Number of Patients With Major Radiation Planning Deviations	0 Participants

SECONDARY outcome

Timeframe: From the start of treatment to 90 days

Population: Eligible patients who started protocol treatment

Outcome measures

Outcome measures
Measure	5-FU + Mitomycin + IMRT n=52 Participants 5-FU + Mitomycin + IMRT
Percentage of Subjects With Acute Adverse Events (AE) GI Grade 2+	73 percentage of participants Interval to 83.0 One-sided confidence interval
Percentage of Subjects With Acute Adverse Events (AE) GU Grade 2+	15 percentage of participants Interval to 28.0 One-sided confidence interval
Percentage of Subjects With Acute Adverse Events (AE) Hematologic Grade 2+	73 percentage of participants Interval to 83.0 One-sided confidence interval
Percentage of Subjects With Acute Adverse Events (AE) Skin Grade 2+	75 percentage of participants Interval to 85.0 One-sided confidence interval
Percentage of Subjects With Acute Adverse Events (AE) Any Grade 2+	94 percentage of participants Interval to 99.0 One-sided confidence interval
Percentage of Subjects With Acute Adverse Events (AE) Any Grade 3+	83 percentage of participants Interval to 91.0 One-sided confidence interval

SECONDARY outcome

Timeframe: From 91 days after start of study treatment to the end of follow-up. Maximum follow-up at time of analysis was 9.2 years.

Population: Eligible patients who started IMRT and were on-study \> 90 days from the start of treatment (or did not withdraw consent until after 90 days).

Highest grade adverse event per subject were counted. Adverse events were graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Late toxicities occur greater than 90 days from the start of treatment.

Outcome measures

Outcome measures
Measure	5-FU + Mitomycin + IMRT n=51 Participants 5-FU + Mitomycin + IMRT
Percentage of Subjects With Late Adverse Events (AE) GI/GU Grade 2+	35 percentage of participants Interval 24.0 to 49.0
Percentage of Subjects With Late Adverse Events (AE) Non-Hematologic Grade 2+	67 percentage of participants Interval 53.0 to 78.0
Percentage of Subjects With Late Adverse Events (AE) Any Grade 2+	75 percentage of participants Interval 61.0 to 81.0
Percentage of Subjects With Late Adverse Events (AE) Any Grade 3+	20 percentage of participants Interval 11.0 to 33.0

SECONDARY outcome

Timeframe: 8 and 12 weeks after treatment completion (corresponding to 14 and 18 weeks from registration)

Population: Eligible patients who started study treatment

A complete clinical response was defined as complete resolution of all palpable tumor determined by digital rectal exam and proctosigmoidoscopy supplemented with pelvic axial imaging.

Outcome measures

Outcome measures
Measure	5-FU + Mitomycin + IMRT n=52 Participants 5-FU + Mitomycin + IMRT
Clinical Complete Response Rate 8 weeks after treatment	64 percentage of participants Interval 50.0 to 75.0
Clinical Complete Response Rate 12 weeks after treatment	81 percentage of participants Interval 68.0 to 89.0

SECONDARY outcome

Timeframe: From start to end of radiation therapy (6 weeks)

Population: Eligible patients who started IMRT

Number of days from radiotherapy treatment start to radiotherapy treatment end

Outcome measures

Outcome measures
Measure	5-FU + Mitomycin + IMRT n=51 Participants 5-FU + Mitomycin + IMRT
Duration of Radiotherapy Treatment	43 Days Interval 32.0 to 59.0

SECONDARY outcome

Timeframe: From registration to 5 years

Population: Eligible patients who started study treatment

Overall survival time is defined as time from registration/randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.

Outcome measures

Outcome measures
Measure	5-FU + Mitomycin + IMRT n=52 Participants 5-FU + Mitomycin + IMRT
Five-year Rate of Overall Survival	76 percentage of participants Interval 61.0 to 86.0

SECONDARY outcome

Timeframe: From registration to 5 years

Population: Eligible patients who started study treatment

Disease-free survival time is defined as time from registration to the date of local-regional failure, the appearance of distant metastases, the appearance of a second primary failure, or date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive without failure are censored at the date of last contact. Local failure is defined as any measurable disease after 12 weeks from the completion of chemoradiation therapy. Local failure is defined as: a) For patients with no disease in pelvic and/or groin nodes, the appearance of disease in pelvic or groin nodes; b) For patients with disease in pelvic and/or groin nodes at study entry, nodal recurrence following clearance or persistent nodal disease for more than 12 weeks after completion of treatment.

Outcome measures

Outcome measures
Measure	5-FU + Mitomycin + IMRT n=52 Participants 5-FU + Mitomycin + IMRT
Five-year Rate of Disease-free Survival	70 percentage of participants Interval 56.0 to 81.0

SECONDARY outcome

Timeframe: From registration to 5 years

Population: Eligible patients who started study treatment

Local-regional failure time is defined as time from registration to date of failure and is estimated by the cumulative incidence method. Patients last known to be alive without failure are censored at the date of last contact. Local-regional failure is defined as a local or regional failure. Local failure is defined as any measurable disease after 12 weeks from the completion of chemoradiation therapy. Regional failure is defined as: a) For patients with no disease in pelvic and/or groin nodes, the appearance of disease in pelvic or groin nodes; b) For patients with disease in pelvic and/or groin nodes at study entry, nodal recurrence following clearance or persistent nodal disease for more than 12 weeks after completion of treatment.

Outcome measures

Outcome measures
Measure	5-FU + Mitomycin + IMRT n=52 Participants 5-FU + Mitomycin + IMRT
Five-Year Cumulative Incidence Rate of Local-regional Failure	16 percentage of participants Interval 7.0 to 27.0

SECONDARY outcome

Timeframe: From registration to 5 years

Population: Eligible patients who started study treatment

Distant failure time is defined as time from registration to the appearance of distant metastases and is estimated by the cumulative incidence method. Patients last known to be alive without failure are censored at the date of last contact.

Outcome measures

Outcome measures
Measure	5-FU + Mitomycin + IMRT n=52 Participants 5-FU + Mitomycin + IMRT
Five-Year Cumulative Incidence Rate of Distant Failure	16 percentage of participants Interval 7.0 to 27.0

SECONDARY outcome

Timeframe: From registration to 5 years

Population: Eligible patients who started study treatment

Colostomy failure time is defined as time from registration to the date of colostomy or abdominoperineal (A-P) resection and is estimated by the cumulative incidence method. Patients last known to be alive without failure are censored at the date of last contact.

Outcome measures

Outcome measures
Measure	5-FU + Mitomycin + IMRT n=52 Participants 5-FU + Mitomycin + IMRT
Five-Year Cumulative Incidence Rate of Colostomy Failure	10 percentage of participants Interval 4.0 to 20.0

SECONDARY outcome

Timeframe: From registration to 5 years

Population: Eligible patients who started study treatment

Colostomy-free survival time is defined as time from registration to date of colostomy or abdominoperineal (A-P) resection, or date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive without failure are censored at the date of last contact.

Outcome measures

Outcome measures
Measure	5-FU + Mitomycin + IMRT n=52 Participants 5-FU + Mitomycin + IMRT
Five-Year Rate of Colostomy-free Survival	74 percentage of participants Interval 59.0 to 84.0

Adverse Events

5-FU + Mitomycin + IMRT

Serious events: 6 serious events

Other events: 52 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	5-FU + Mitomycin + IMRT n=52 participants at risk 5-FU + Mitomycin + IMRT
Blood and lymphatic system disorders Anemia	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Atrial fibrillation	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Sinus bradycardia	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Abdominal pain	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Constipation	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Diarrhea	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Enterocolitis	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Esophagitis	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Mucositis oral	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Nausea	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Vomiting	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Dermatitis radiation	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Vascular access complication	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Creatinine increased	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Dehydration	3.8% 2/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Cystitis noninfective	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Urinary frequency	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Urinary incontinence	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Urinary tract obstruction	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Reproductive system and breast disorders Perineal pain	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.

Other adverse events

Other adverse events
Measure	5-FU + Mitomycin + IMRT n=52 participants at risk 5-FU + Mitomycin + IMRT
Blood and lymphatic system disorders Anemia	67.3% 35/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other	3.8% 2/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Blood and lymphatic system disorders Disseminated intravascular coagulation	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Blood and lymphatic system disorders Febrile neutropenia	13.5% 7/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Atrial fibrillation	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Cardiac disorders - Other	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Paroxysmal atrial tachycardia	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Sinus tachycardia	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Abdominal distension	3.8% 2/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Abdominal pain	25.0% 13/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Anal fistula	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Anal hemorrhage	9.6% 5/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Anal pain	28.8% 15/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Anal stenosis	5.8% 3/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Colitis	3.8% 2/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Colonic hemorrhage	3.8% 2/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Constipation	34.6% 18/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Diarrhea	80.8% 42/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Duodenal hemorrhage	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Dyspepsia	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Dysphagia	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Enterocolitis	5.8% 3/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Esophageal pain	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Fecal incontinence	13.5% 7/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Flatulence	5.8% 3/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Gastrointestinal disorders - Other	13.5% 7/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Hemorrhoids	11.5% 6/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Mucositis oral	48.1% 25/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Nausea	53.8% 28/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Oral pain	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Proctitis	30.8% 16/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Rectal hemorrhage	26.9% 14/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Rectal pain	19.2% 10/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Rectal ulcer	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Small intestinal obstruction	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Stomach pain	3.8% 2/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Vomiting	23.1% 12/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Chills	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Death NOS	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Edema limbs	13.5% 7/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Edema trunk	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Fatigue	63.5% 33/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Fever	7.7% 4/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders General disorders and administration site conditions - Other	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Non-cardiac chest pain	5.8% 3/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Pain	13.5% 7/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Hepatobiliary disorders Hepatobiliary disorders - Other	3.8% 2/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Immune system disorders Allergic reaction	3.8% 2/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Bladder infection	5.8% 3/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infections and infestations - Other	13.5% 7/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Lung infection	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Skin infection	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Urinary tract infection	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Burn	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Dermatitis radiation	59.6% 31/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Radiation recall reaction (dermatologic)	17.3% 9/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Vascular access complication	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Wound dehiscence	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Alanine aminotransferase increased	9.6% 5/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Alkaline phosphatase increased	5.8% 3/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Aspartate aminotransferase increased	11.5% 6/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Blood bilirubin increased	3.8% 2/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations CD4 lymphocytes decreased	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations CPK increased	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Cholesterol high	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Creatinine increased	3.8% 2/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Investigations - Other	11.5% 6/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Lymphocyte count decreased	13.5% 7/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Neutrophil count decreased	63.5% 33/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Platelet count decreased	61.5% 32/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Weight loss	23.1% 12/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations White blood cell decreased	63.5% 33/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Anorexia	36.5% 19/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Dehydration	23.1% 12/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypercalcemia	3.8% 2/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hyperglycemia	26.9% 14/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hyperkalemia	3.8% 2/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypoalbuminemia	36.5% 19/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypocalcemia	23.1% 12/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypoglycemia	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypokalemia	25.0% 13/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hyponatremia	30.8% 16/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypophosphatemia	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Arthralgia	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Back pain	5.8% 3/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Bone pain	3.8% 2/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Buttock pain	3.8% 2/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Muscle weakness right-sided	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Myalgia	5.8% 3/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Pain in extremity	7.7% 4/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Pelvic soft tissue necrosis	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Dizziness	11.5% 6/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Dysgeusia	9.6% 5/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Headache	7.7% 4/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Nervous system disorders - Other	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Peripheral motor neuropathy	5.8% 3/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Peripheral sensory neuropathy	15.4% 8/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Seizure	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Syncope	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Agitation	3.8% 2/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Anxiety	11.5% 6/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Confusion	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Depression	9.6% 5/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Insomnia	7.7% 4/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Libido decreased	3.8% 2/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Acute kidney injury	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Cystitis noninfective	15.4% 8/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Hematuria	3.8% 2/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Renal and urinary disorders - Other	9.6% 5/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Urinary frequency	34.6% 18/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Urinary incontinence	3.8% 2/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Urinary retention	5.8% 3/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Urinary tract pain	7.7% 4/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Urine discoloration	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Reproductive system and breast disorders Erectile dysfunction	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Reproductive system and breast disorders Irregular menstruation	3.8% 2/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Reproductive system and breast disorders Pelvic pain	3.8% 2/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Reproductive system and breast disorders Penile pain	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Reproductive system and breast disorders Perineal pain	17.3% 9/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Reproductive system and breast disorders Reproductive system and breast disorders - Other	7.7% 4/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Reproductive system and breast disorders Scrotal pain	5.8% 3/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Reproductive system and breast disorders Vaginal discharge	3.8% 2/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Reproductive system and breast disorders Vaginal dryness	11.5% 6/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Reproductive system and breast disorders Vaginal hemorrhage	3.8% 2/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Reproductive system and breast disorders Vaginal inflammation	3.8% 2/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Reproductive system and breast disorders Vaginal obstruction	9.6% 5/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Reproductive system and breast disorders Vaginal pain	7.7% 4/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Cough	11.5% 6/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Dyspnea	11.5% 6/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Epistaxis	3.8% 2/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Hypoxia	3.8% 2/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	7.7% 4/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.8% 2/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Pneumonitis	5.8% 3/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Alopecia	23.1% 12/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Dry skin	7.7% 4/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Erythema multiforme	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Hyperhidrosis	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Pain of skin	3.8% 2/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Pruritus	7.7% 4/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Rash maculo-papular	17.3% 9/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	3.8% 2/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Skin atrophy	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	23.1% 12/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Skin hypopigmentation	5.8% 3/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Skin induration	7.7% 4/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Skin ulceration	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Telangiectasia	3.8% 2/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Vascular disorders Flushing	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Vascular disorders Hot flashes	7.7% 4/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Vascular disorders Hypertension	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Vascular disorders Thromboembolic event	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Vascular disorders Vascular disorders - Other	1.9% 1/52 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.

Additional Information

Wendy Seiferheld

Radiation Therapy Oncology Group (RTOG)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place