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Trial record 4 of 7 for:    "Cloacogenic Carcinoma" | "Immunosuppressive Agents"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00423293
Recruitment Status : Completed
First Posted : January 18, 2007
Results First Posted : May 29, 2013
Last Update Posted : February 27, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Anal Cancer
Interventions Drug: fluorouracil
Drug: mitomycin C
Radiation: Intensity-modulated radiation therapy
Enrollment 63
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 5-FU + Mitomycin + IMRT
Hide Arm/Group Description 5-FU + Mitomycin + IMRT
Period Title: Overall Study
Started 63
Completed 52 [1]
Not Completed 11
Reason Not Completed
Ineligible / No protocol treatment             11
[1]
Subjects contributing data to the primary analysis are considered to have completed the study.
Arm/Group Title 5-FU + Mitomycin + IMRT
Hide Arm/Group Description 5-FU + Mitomycin + IMRT
Overall Number of Baseline Participants 52
Hide Baseline Analysis Population Description
All eligible patients
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 52 participants
58
(34 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants
Female
42
  80.8%
Male
10
  19.2%
1.Primary Outcome
Title 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)
Hide Description 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.
Time Frame From the start of treatment to 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with adverse event information.
Arm/Group Title 5-FU + Mitomycin + IMRT
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5-FU + Mitomycin + IMRT
Overall Number of Participants Analyzed 52
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
77 [1] 
(NA to 87)
[1]
This is a one-sided confidence interval.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 5-FU + Mitomycin + IMRT
Comments The RT+ 5-FU + Mitomycin-C arm on previous Radiation Therapy Oncology Group (RTOG) study 9811 [NCT00003596] had a 77% rate of >= grade 2 GI and GU adverse events. The null hypothesis for this study design was a 15% reduction for that rate. Fifty-four evaluable patients provides 80% power to detect a 15% reduction, using a one-sided chi-squared test with a type I error rate of 0.05. (With 52 patients, the power is reduced to 78%.)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments One-sided p-value comparing to a rate of 78% (the historical rate was updated after the study design).
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Number of Patients With Major Radiation Planning Deviations
Hide Description Deviations in intensity-modulated radiation therapy technique (IMRT) planning were determined by central review by the radiation oncology co-chairs of the study.
Time Frame Planning occurred prior to radiation therapy
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started IMRT
Arm/Group Title 5-FU + Mitomycin + IMRT
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5-FU + Mitomycin + IMRT
Overall Number of Participants Analyzed 51
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3.Secondary Outcome
Title Percentage of Subjects With Acute Adverse Events (AE)
Hide Description 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.
Time Frame From the start of treatment to 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started protocol treatment
Arm/Group Title 5-FU + Mitomycin + IMRT
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5-FU + Mitomycin + IMRT
Overall Number of Participants Analyzed 52
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
GI Grade 2+
73 [1] 
(NA to 83)
GU Grade 2+
15 [1] 
(NA to 28)
Hematologic Grade 2+
73 [1] 
(NA to 83)
Skin Grade 2+
75 [1] 
(NA to 85)
Any Grade 2+
94 [1] 
(NA to 99)
Any Grade 3+
83 [1] 
(NA to 91)
[1]
One-sided confidence interval
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 5-FU + Mitomycin + IMRT
Comments Percentage of patients with GI grade 2+ adverse events were compared to the historical rate of 73%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5
Comments [Not Specified]
Method Chi-squared
Comments One-sided significance level = 0.05
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 5-FU + Mitomycin + IMRT
Comments Percentage of patients with GU grade 2+ adverse events were compared to the historical rate of 20%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments [Not Specified]
Method Chi-squared
Comments One-sided significance level = 0.05
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 5-FU + Mitomycin + IMRT
Comments Percentage of patients with hematologic grade 2+ adverse events were compared to the historical rate of 85%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.032
Comments [Not Specified]
Method Chi-squared
Comments One-sided significance level = 0.05
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 5-FU + Mitomycin + IMRT
Comments Percentage of patients with skin grade 2+ adverse events were compared to the historical rate of 83%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method Chi-squared
Comments One-sided significance level = 0.05
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 5-FU + Mitomycin + IMRT
Comments Percentage of patients with any grade 2+ adverse events were compared to the historical rate of 98%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments [Not Specified]
Method Chi-squared
Comments One-sided significance level = 0.05
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 5-FU + Mitomycin + IMRT
Comments Percentage of patients with any grade 3+ adverse events were compared to the historical rate of 87%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.23
Comments [Not Specified]
Method Chi-squared
Comments One-sided significance level = 0.05
4.Secondary Outcome
Title Percentage of Subjects With Late Adverse Events (AE)
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title 5-FU + Mitomycin + IMRT
Hide Arm/Group Description:
5-FU + Mitomycin + IMRT
Overall Number of Participants Analyzed 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
GI/GU Grade 2+
35
(24 to 49)
Non-Hematologic Grade 2+
67
(53 to 78)
Any Grade 2+
75
(61 to 81)
Any Grade 3+
20
(11 to 33)
5.Secondary Outcome
Title Clinical Complete Response Rate
Hide Description 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.
Time Frame 8 and 12 weeks after treatment completion (corresponding to 14 and 18 weeks from registration)
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title 5-FU + Mitomycin + IMRT
Hide Arm/Group Description:
5-FU + Mitomycin + IMRT
Overall Number of Participants Analyzed 52
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
8 weeks after treatment
64
(50 to 75)
12 weeks after treatment
81
(68 to 89)
6.Secondary Outcome
Title Duration of Radiotherapy Treatment
Hide Description Number of days from radiotherapy treatment start to radiotherapy treatment end
Time Frame From start to end of radiation therapy (6 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started IMRT
Arm/Group Title 5-FU + Mitomycin + IMRT
Hide Arm/Group Description:
5-FU + Mitomycin + IMRT
Overall Number of Participants Analyzed 51
Median (Full Range)
Unit of Measure: Days
43
(32 to 59)
7.Secondary Outcome
Title Five-year Rate of Overall Survival
Hide Description 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.
Time Frame From registration to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title 5-FU + Mitomycin + IMRT
Hide Arm/Group Description:
5-FU + Mitomycin + IMRT
Overall Number of Participants Analyzed 52
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
76
(61 to 86)
8.Secondary Outcome
Title Five-year Rate of Disease-free Survival
Hide Description 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.
Time Frame From registration to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title 5-FU + Mitomycin + IMRT
Hide Arm/Group Description:
5-FU + Mitomycin + IMRT
Overall Number of Participants Analyzed 52
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
70
(56 to 81)
9.Secondary Outcome
Title Five-Year Cumulative Incidence Rate of Local-regional Failure
Hide Description 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.
Time Frame From registration to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title 5-FU + Mitomycin + IMRT
Hide Arm/Group Description:
5-FU + Mitomycin + IMRT
Overall Number of Participants Analyzed 52
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
16
(7 to 27)
10.Secondary Outcome
Title Five-Year Cumulative Incidence Rate of Distant Failure
Hide Description 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.
Time Frame From registration to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title 5-FU + Mitomycin + IMRT
Hide Arm/Group Description:
5-FU + Mitomycin + IMRT
Overall Number of Participants Analyzed 52
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
16
(7 to 27)
11.Secondary Outcome
Title Five-Year Cumulative Incidence Rate of Colostomy Failure
Hide Description 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.
Time Frame From registration to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title 5-FU + Mitomycin + IMRT
Hide Arm/Group Description:
5-FU + Mitomycin + IMRT
Overall Number of Participants Analyzed 52
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
10
(4 to 20)
12.Secondary Outcome
Title Five-Year Rate of Colostomy-free Survival
Hide Description 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.
Time Frame From registration to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title 5-FU + Mitomycin + IMRT
Hide Arm/Group Description:
5-FU + Mitomycin + IMRT
Overall Number of Participants Analyzed 52
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
74
(59 to 84)
Time Frame [Not Specified]
Adverse Event Reporting Description 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.
 
Arm/Group Title 5-FU + Mitomycin + IMRT
Hide Arm/Group Description 5-FU + Mitomycin + IMRT
All-Cause Mortality
5-FU + Mitomycin + IMRT
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
5-FU + Mitomycin + IMRT
Affected / at Risk (%)
Total   6/52 (11.54%) 
Blood and lymphatic system disorders   
Anemia * 1  1/52 (1.92%) 
Cardiac disorders   
Atrial fibrillation * 1  1/52 (1.92%) 
Sinus bradycardia * 1  1/52 (1.92%) 
Gastrointestinal disorders   
Abdominal pain * 1  1/52 (1.92%) 
Constipation * 1  1/52 (1.92%) 
Diarrhea * 1  1/52 (1.92%) 
Enterocolitis * 1  1/52 (1.92%) 
Esophagitis * 1  1/52 (1.92%) 
Mucositis oral * 1  1/52 (1.92%) 
Nausea * 1  1/52 (1.92%) 
Vomiting * 1  1/52 (1.92%) 
Injury, poisoning and procedural complications   
Dermatitis radiation * 1  1/52 (1.92%) 
Vascular access complication * 1  1/52 (1.92%) 
Investigations   
Creatinine increased * 1  1/52 (1.92%) 
Metabolism and nutrition disorders   
Dehydration * 1  2/52 (3.85%) 
Renal and urinary disorders   
Cystitis noninfective * 1  1/52 (1.92%) 
Urinary frequency * 1  1/52 (1.92%) 
Urinary incontinence * 1  1/52 (1.92%) 
Urinary tract obstruction * 1  1/52 (1.92%) 
Reproductive system and breast disorders   
Perineal pain * 1  1/52 (1.92%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
5-FU + Mitomycin + IMRT
Affected / at Risk (%)
Total   52/52 (100.00%) 
Blood and lymphatic system disorders   
Anemia * 1  35/52 (67.31%) 
Blood and lymphatic system disorders - Other * 1  2/52 (3.85%) 
Disseminated intravascular coagulation * 1  1/52 (1.92%) 
Febrile neutropenia * 1  7/52 (13.46%) 
Cardiac disorders   
Atrial fibrillation * 1  1/52 (1.92%) 
Cardiac disorders - Other * 1  1/52 (1.92%) 
Paroxysmal atrial tachycardia * 1  1/52 (1.92%) 
Sinus tachycardia * 1  1/52 (1.92%) 
Gastrointestinal disorders   
Abdominal distension * 1  2/52 (3.85%) 
Abdominal pain * 1  13/52 (25.00%) 
Anal fistula * 1  1/52 (1.92%) 
Anal hemorrhage * 1  5/52 (9.62%) 
Anal pain * 1  15/52 (28.85%) 
Anal stenosis * 1  3/52 (5.77%) 
Colitis * 1  2/52 (3.85%) 
Colonic hemorrhage * 1  2/52 (3.85%) 
Constipation * 1  18/52 (34.62%) 
Diarrhea * 1  42/52 (80.77%) 
Duodenal hemorrhage * 1  1/52 (1.92%) 
Dyspepsia * 1  1/52 (1.92%) 
Dysphagia * 1  1/52 (1.92%) 
Enterocolitis * 1  3/52 (5.77%) 
Esophageal pain * 1  1/52 (1.92%) 
Fecal incontinence * 1  7/52 (13.46%) 
Flatulence * 1  3/52 (5.77%) 
Gastrointestinal disorders - Other * 1  7/52 (13.46%) 
Hemorrhoids * 1  6/52 (11.54%) 
Lower gastrointestinal hemorrhage * 1  1/52 (1.92%) 
Mucositis oral * 1  25/52 (48.08%) 
Nausea * 1  28/52 (53.85%) 
Oral pain * 1  1/52 (1.92%) 
Proctitis * 1  16/52 (30.77%) 
Rectal hemorrhage * 1  14/52 (26.92%) 
Rectal pain * 1  10/52 (19.23%) 
Rectal ulcer * 1  1/52 (1.92%) 
Small intestinal obstruction * 1  1/52 (1.92%) 
Stomach pain * 1  2/52 (3.85%) 
Vomiting * 1  12/52 (23.08%) 
General disorders   
Chills * 1  1/52 (1.92%) 
Death NOS * 1  1/52 (1.92%) 
Edema limbs * 1  7/52 (13.46%) 
Edema trunk * 1  1/52 (1.92%) 
Fatigue * 1  33/52 (63.46%) 
Fever * 1  4/52 (7.69%) 
General disorders and administration site conditions - Other * 1  1/52 (1.92%) 
Non-cardiac chest pain * 1  3/52 (5.77%) 
Pain * 1  7/52 (13.46%) 
Hepatobiliary disorders   
Hepatobiliary disorders - Other * 1  2/52 (3.85%) 
Immune system disorders   
Allergic reaction * 1  2/52 (3.85%) 
Infections and infestations   
Bladder infection * 1  3/52 (5.77%) 
Infections and infestations - Other * 1  7/52 (13.46%) 
Lung infection * 1  1/52 (1.92%) 
Skin infection * 1  1/52 (1.92%) 
Urinary tract infection * 1  1/52 (1.92%) 
Injury, poisoning and procedural complications   
Burn * 1  1/52 (1.92%) 
Dermatitis radiation * 1  31/52 (59.62%) 
Radiation recall reaction (dermatologic) * 1  9/52 (17.31%) 
Vascular access complication * 1  1/52 (1.92%) 
Wound dehiscence * 1  1/52 (1.92%) 
Investigations   
Alanine aminotransferase increased * 1  5/52 (9.62%) 
Alkaline phosphatase increased * 1  3/52 (5.77%) 
Aspartate aminotransferase increased * 1  6/52 (11.54%) 
Blood bilirubin increased * 1  2/52 (3.85%) 
CD4 lymphocytes decreased * 1  1/52 (1.92%) 
CPK increased * 1  1/52 (1.92%) 
Cholesterol high * 1  1/52 (1.92%) 
Creatinine increased * 1  2/52 (3.85%) 
Investigations - Other * 1  6/52 (11.54%) 
Lymphocyte count decreased * 1  7/52 (13.46%) 
Neutrophil count decreased * 1  33/52 (63.46%) 
Platelet count decreased * 1  32/52 (61.54%) 
Weight loss * 1  12/52 (23.08%) 
White blood cell decreased * 1  33/52 (63.46%) 
Metabolism and nutrition disorders   
Anorexia * 1  19/52 (36.54%) 
Dehydration * 1  12/52 (23.08%) 
Hypercalcemia * 1  2/52 (3.85%) 
Hyperglycemia * 1  14/52 (26.92%) 
Hyperkalemia * 1  2/52 (3.85%) 
Hypoalbuminemia * 1  19/52 (36.54%) 
Hypocalcemia * 1  12/52 (23.08%) 
Hypoglycemia * 1  1/52 (1.92%) 
Hypokalemia * 1  13/52 (25.00%) 
Hyponatremia * 1  16/52 (30.77%) 
Hypophosphatemia * 1  1/52 (1.92%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  1/52 (1.92%) 
Back pain * 1  3/52 (5.77%) 
Bone pain * 1  2/52 (3.85%) 
Buttock pain * 1  2/52 (3.85%) 
Generalized muscle weakness * 1  1/52 (1.92%) 
Muscle weakness right-sided * 1  1/52 (1.92%) 
Musculoskeletal and connective tissue disorder - Other * 1  1/52 (1.92%) 
Myalgia * 1  3/52 (5.77%) 
Pain in extremity * 1  4/52 (7.69%) 
Pelvic soft tissue necrosis * 1  1/52 (1.92%) 
Nervous system disorders   
Dizziness * 1  6/52 (11.54%) 
Dysgeusia * 1  5/52 (9.62%) 
Headache * 1  4/52 (7.69%) 
Nervous system disorders - Other * 1  1/52 (1.92%) 
Peripheral motor neuropathy * 1  3/52 (5.77%) 
Peripheral sensory neuropathy * 1  8/52 (15.38%) 
Seizure * 1  1/52 (1.92%) 
Syncope * 1  1/52 (1.92%) 
Psychiatric disorders   
Agitation * 1  2/52 (3.85%) 
Anxiety * 1  6/52 (11.54%) 
Confusion * 1  1/52 (1.92%) 
Depression * 1  5/52 (9.62%) 
Insomnia * 1  4/52 (7.69%) 
Libido decreased * 1  2/52 (3.85%) 
Renal and urinary disorders   
Acute kidney injury * 1  1/52 (1.92%) 
Cystitis noninfective * 1  8/52 (15.38%) 
Hematuria * 1  2/52 (3.85%) 
Renal and urinary disorders - Other * 1  5/52 (9.62%) 
Urinary frequency * 1  18/52 (34.62%) 
Urinary incontinence * 1  2/52 (3.85%) 
Urinary retention * 1  3/52 (5.77%) 
Urinary tract pain * 1  4/52 (7.69%) 
Urine discoloration * 1  1/52 (1.92%) 
Reproductive system and breast disorders   
Erectile dysfunction * 1  1/52 (1.92%) 
Irregular menstruation * 1  2/52 (3.85%) 
Pelvic pain * 1  2/52 (3.85%) 
Penile pain * 1  1/52 (1.92%) 
Perineal pain * 1  9/52 (17.31%) 
Reproductive system and breast disorders - Other * 1  4/52 (7.69%) 
Scrotal pain * 1  3/52 (5.77%) 
Vaginal discharge * 1  2/52 (3.85%) 
Vaginal dryness * 1  6/52 (11.54%) 
Vaginal hemorrhage * 1  2/52 (3.85%) 
Vaginal inflammation * 1  2/52 (3.85%) 
Vaginal obstruction * 1  5/52 (9.62%) 
Vaginal pain * 1  4/52 (7.69%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  6/52 (11.54%) 
Dyspnea * 1  6/52 (11.54%) 
Epistaxis * 1  2/52 (3.85%) 
Hypoxia * 1  2/52 (3.85%) 
Pharyngolaryngeal pain * 1  4/52 (7.69%) 
Pleural effusion * 1  2/52 (3.85%) 
Pneumonitis * 1  3/52 (5.77%) 
Respiratory, thoracic and mediastinal disorders - Other * 1  1/52 (1.92%) 
Skin and subcutaneous tissue disorders   
Alopecia * 1  12/52 (23.08%) 
Dry skin * 1  4/52 (7.69%) 
Erythema multiforme * 1  1/52 (1.92%) 
Hyperhidrosis * 1  1/52 (1.92%) 
Pain of skin * 1  2/52 (3.85%) 
Pruritus * 1  4/52 (7.69%) 
Rash maculo-papular * 1  9/52 (17.31%) 
Skin and subcutaneous tissue disorders - Other * 1  2/52 (3.85%) 
Skin atrophy * 1  1/52 (1.92%) 
Skin hyperpigmentation * 1  12/52 (23.08%) 
Skin hypopigmentation * 1  3/52 (5.77%) 
Skin induration * 1  4/52 (7.69%) 
Skin ulceration * 1  1/52 (1.92%) 
Telangiectasia * 1  2/52 (3.85%) 
Vascular disorders   
Flushing * 1  1/52 (1.92%) 
Hot flashes * 1  4/52 (7.69%) 
Hypertension * 1  1/52 (1.92%) 
Thromboembolic event * 1  1/52 (1.92%) 
Vascular disorders - Other * 1  1/52 (1.92%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Wendy Seiferheld
Organization: Radiation Therapy Oncology Group (RTOG)
EMail: wseiferheld@acr.org
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Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00423293     History of Changes
Other Study ID Numbers: RTOG-0529
CDR0000524057
First Submitted: January 16, 2007
First Posted: January 18, 2007
Results First Submitted: April 11, 2013
Results First Posted: May 29, 2013
Last Update Posted: February 27, 2019