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Standard Versus Intensity-Modulated Pelvic Radiation Therapy in Treating Patients With Endometrial or Cervical Cancer

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ClinicalTrials.gov Identifier: NCT01672892
Recruitment Status : Active, not recruiting
First Posted : August 27, 2012
Results First Posted : January 23, 2018
Last Update Posted : April 24, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cervical Cancer
Endometrial Cancer
Gastrointestinal Complications
Perioperative/Postoperative Complications
Radiation Toxicity
Urinary Complications
Urinary Tract Toxicity
Interventions Radiation: Standard radiation therapy
Radiation: intensity-modulated radiation therapy
Enrollment 289

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intensity-Modulated Radiation Therapy Standard Radiation Therapy
Hide Arm/Group Description Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
Period Title: Overall Study
Started 137 152
Completed 129 [1] 149 [1]
Not Completed 8 3
Reason Not Completed
Protocol Violation             8             3
[1]
Eligible subjects available for analysis
Arm/Group Title Intensity-Modulated Radiation Therapy Standard Radiation Therapy Total
Hide Arm/Group Description Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy Total of all reporting groups
Overall Number of Baseline Participants 129 149 278
Hide Baseline Analysis Population Description
Eligible patients
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 129 participants 149 participants 278 participants
62
(28 to 82)
61
(29 to 83)
61
(28 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants 149 participants 278 participants
Female
129
 100.0%
149
 100.0%
278
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Acute Gastrointestinal Toxicity, as Measured by Change in Expanded Prostate Cancer Index Composite (EPIC) Bowel Domain Score at 5 Weeks From the Start of Pelvic Radiation
Hide Description The primary endpoint is change in acute GI toxicity, as measured by the EPIC bowel domain, from baseline to 5 weeks after the first fraction of radiation is delivered. The EPIC has four domains (bowel, urinary, sexual, and hormonal) that have been validated separately, which allows use of only the domains of interest. The EPIC bowel domain consists of 14 items and has a function subscale (7 items) and bother subscale (7 items). For each domain, responses form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, where higher scores correspond to better quality of life. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Change was calculated as follow-up score – baseline score so a negative change score indicates a decline in function.
Time Frame Baseline and week 5 of RT
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with EPIC bowel domain completed at baseline and 5 weeks
Arm/Group Title Intensity-Modulated Radiation Therapy Standard Radiation Therapy
Hide Arm/Group Description:
Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy
Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
Overall Number of Participants Analyzed 107 126
Mean (Standard Deviation)
Unit of Measure: units on a scale
-18.6  (18.7) -23.6  (19.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intensity-Modulated Radiation Therapy, Standard Radiation Therapy
Comments Since there is no prior data using this tool in this patient population, an effect size of 0.4 was chosen to calculate sample size. Based on a two-sample t-test with one interim look and a two-sided alpha=0.05, a sample size of 225 is needed to achieve 85% statistical power. Assuming an attrition rate of 10% and noncompliance of 10%, 281 patients were required in order to ensure 225 evaluable patients for the primary endpoint analysis.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0476
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
2.Secondary Outcome
Title Validation of EPIC Bowel and Urinary Domains
Hide Description Since the EPIC has not been validated in this patient population, a secondary endpoint is to validate the bowel and urinary domains of EPIC in women undergoing either IMRT pelvic radiation treatment or four field pelvic radiation treatments for endometrial or cervical cancer. The bowel and urinary domains of the EPIC can be administered individually since they are separate and distinct modules of the robust and comprehensive EPIC tool.
Time Frame Before study start, Week 3 of RT, Week 5 of RT, 4-6 Weeks after RT, 1 year from start of RT and 3 years from start of RT
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Percentage of Patients With Acute Grade 2+ GI Toxicity at 5 Weeks From the Start of Treatment
Hide Description Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE. The Common Terminology Criteria for Adverse Events (CTCAE) v4.0 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.
Time Frame Baseline to Week 5 of RT
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with toxicity data
Arm/Group Title Intensity-Modulated Radiation Therapy Standard Radiation Therapy
Hide Arm/Group Description:
Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy
Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
Overall Number of Participants Analyzed 122 136
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
26.2
(18.4 to 34.4)
22.1
(15.1 to 29.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intensity-Modulated Radiation Therapy, Standard Radiation Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4338
Comments [Not Specified]
Method Binomial test of proportions
Comments 2-sided significance level = 0.05
4.Secondary Outcome
Title Urinary Toxicity, as Measured by Change in EPIC Urinary Domain
Hide Description The primary endpoint is change in acute GI toxicity, as measured by the EPIC urinary domain, from baseline to 5 weeks after the first fraction of radiation is delivered. The EPIC has four domains (bowel, urinary, sexual, and hormonal) that have been validated separately, which allows use of only the domains of interest. The EPIC urinary domain consists of 12 items and has a function subscale (5 items) and bother subscale (7 items). For each domain, responses form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, where higher scores correspond to better quality of life. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Change was calculated as follow-up score – baseline score so a negative change score indicates a decline in function.
Time Frame Baseline, week 3 and 5 of RT, and 4-6 weeks after RT
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with the questionnaire completed at baseline and respective follow-up time point
Arm/Group Title Intensity-Modulated Radiation Therapy Standard Radiation Therapy
Hide Arm/Group Description:
Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy
Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
Overall Number of Participants Analyzed 110 127
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 3 of RT Number Analyzed 110 participants 127 participants
-2.5  (11.3) -6.0  (14.5)
Week 5 of RT Number Analyzed 107 participants 126 participants
-5.6  (15.3) -10.4  (17.5)
4-6 Weeks Post-RT Number Analyzed 99 participants 121 participants
-2.7  (13.0) -4.1  (12.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intensity-Modulated Radiation Therapy, Standard Radiation Therapy
Comments Week 3 of RT
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method t-test, 2 sided
Comments 2-sided significance level of 0.05
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Intensity-Modulated Radiation Therapy, Standard Radiation Therapy
Comments Week 5 of RT
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method t-test, 2 sided
Comments 2-sided significance level of 0.05
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Intensity-Modulated Radiation Therapy, Standard Radiation Therapy
Comments 4-6 weeks post-RT
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method t-test, 2 sided
Comments 2-sided significance level of 0.05
5.Secondary Outcome
Title Quality of Life, as Measured by Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) and FACT-Cx (Cervix) Subscale
Hide Description The FACT-G is a validated, 27-item measure where a higher score represents higher QOL. In addition to a total QOL score, subscale scores for physical, functional, social and emotional well-being are produced. There are 5 responses options, with 0=Not a lot and 4=Very much. All items in a subscale are added together to obtain subscale totals. Scores range from 0-108 for the FACT-G total score, 0-28 for physical, social, functional, and 0-24 for emotional subscale. Certain items must be reversed before it is added by subtracting the response from 4. Subscale totals are summed to form the FACT-G total score. The FACT-Cx is 5-items, with score ranging 0-60, but is not included in total FACT-G. Each subscale requires >= 50% of items completed and overall response rate must be greater than 80%. If items are missing, the subscale scores can be prorated. Change calculated as follow-up score - baseline score so that a negative change score indicates a decline in function.
Time Frame Before study start, Week 5 of RT, 4-6 Weeks after RT, 1 year from start of RT and 3 years from start of RT
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with the questionnaire completed at baseline and respective follow-up time point
Arm/Group Title Intensity-Modulated Radiation Therapy Standard Radiation Therapy
Hide Arm/Group Description:
Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy
Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
Overall Number of Participants Analyzed 110 125
Mean (Standard Deviation)
Unit of Measure: units on a scale
FACT-G total - 5 weeks Number Analyzed 85 participants 104 participants
-6.4  (12.7) -7.6  (13.4)
FACT-G total 4-6 weeks post-RT Number Analyzed 80 participants 100 participants
-0.2  (11.7) 0.5  (13.9)
FACT-Cx subscale - 5 weeks Number Analyzed 87 participants 104 participants
-2.7  (6.1) -4.9  (6.5)
FACT-Cx subscale - 4-6 weeks post-RT Number Analyzed 81 participants 100 participants
-0.3  (5.7) 0.4  (5.7)
Physical subscale - 5 weeks Number Analyzed 86 participants 106 participants
-4.2  (6.0) -6.1  (6.1)
Physical - subscale - 4-6 weeks post-RT Number Analyzed 81 participants 101 participants
-1.1  (4.9) -1.2  (4.8)
Functional subscale - 5 weeks Number Analyzed 87 participants 105 participants
-2.1  (5.7) -1.6  (5.9)
Functional - subscale - 4-6 weeks post-RT Number Analyzed 81 participants 100 participants
-0.1  (5.0) 0.6  (5.4)
Emotional subscale - 5 weeks Number Analyzed 87 participants 106 participants
0.7  (3.5) 0.9  (3.7)
Emotional subscale - 4-6 weeks post-RT Number Analyzed 81 participants 101 participants
1.1  (3.1) 1.9  (3.7)
Social subscale - 5 weeks Number Analyzed 85 participants 106 participants
-0.9  (5.4) -0.6  (5.2)
Social subscale - 4-6 weeks post-RT Number Analyzed 80 participants 101 participants
0.0  (4.8) -0.8  (6.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intensity-Modulated Radiation Therapy, Standard Radiation Therapy
Comments FACT-G total score - 5 weeks
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments [Not Specified]
Method t-test, 2 sided
Comments 2-sided significance level = 0.05
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Intensity-Modulated Radiation Therapy, Standard Radiation Therapy
Comments FACT-G total score - 4-6 weeks post RT
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.72
Comments [Not Specified]
Method t-test, 2 sided
Comments FACT-G total score - 4-6 weeks post RT
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Intensity-Modulated Radiation Therapy, Standard Radiation Therapy
Comments FACT-Cx subscale score - 5 weeks
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments 2-sided significance level = 0.05
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Intensity-Modulated Radiation Therapy, Standard Radiation Therapy
Comments FACT-Cx subscale score - 4-6 weeks post RT
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments [Not Specified]
Method t-test, 2 sided
Comments 2-sided significance level = 0.05
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Intensity-Modulated Radiation Therapy, Standard Radiation Therapy
Comments Physical subscale score - 5 weeks
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method t-test, 2 sided
Comments 2-sided significance level = 0.0125
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Intensity-Modulated Radiation Therapy, Standard Radiation Therapy
Comments Physical subscale score - 4-6 weeks post RT
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9
Comments [Not Specified]
Method t-test, 2 sided
Comments 2-sided significance level = 0.0125
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Intensity-Modulated Radiation Therapy, Standard Radiation Therapy
Comments Functional subscale score - 5 weeks
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.55
Comments [Not Specified]
Method t-test, 2 sided
Comments 2-sided significance level = 0.0125
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Intensity-Modulated Radiation Therapy, Standard Radiation Therapy
Comments Functional subscale score - 4-6 weeks post RT
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method t-test, 2 sided
Comments 2-sided significance level = 0.0125
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Intensity-Modulated Radiation Therapy, Standard Radiation Therapy
Comments Emotional subscale score - 5 weeks
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.66
Comments [Not Specified]
Method t-test, 2 sided
Comments 2-sided significance level = 0.0125
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Intensity-Modulated Radiation Therapy, Standard Radiation Therapy
Comments Emotional subscale score - 4-6 weeks post RT
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method t-test, 2 sided
Comments 2-sided significance level = 0.0125
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Intensity-Modulated Radiation Therapy, Standard Radiation Therapy
Comments Social subscale score - 5 weeks
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.66
Comments [Not Specified]
Method t-test, 2 sided
Comments 2-sided significance level = 0.0125
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Intensity-Modulated Radiation Therapy, Standard Radiation Therapy
Comments Social subscale score - 4-6 weeks post RT
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method t-test, 2 sided
Comments 2-sided significance level = 0.0125
6.Secondary Outcome
Title Health Utilities, as Measured by Change From Baseline in EQ-5D
Hide Description The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). Health states are defined by the combination of the leveled responses to the 5 dimensions, generating 243 health states to which unconsciousness and death are added. The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Both the 5-item index score and the VAS score are transformed into a utility score between 0 (worst health state) and 1 (best health state). Change from baseline is calculated as score at the timepoint of interested - baseline score.
Time Frame Baseline, week 5 of RT, 4-6 weeks after RT
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with the questionnaire completed at baseline and respective follow-up time point
Arm/Group Title Intensity-Modulated Radiation Therapy Standard Radiation Therapy
Hide Arm/Group Description:
Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy
Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
Overall Number of Participants Analyzed 78 91
Mean (Standard Deviation)
Unit of Measure: units on a scale
5 weeks 0  (0.2) 0  (0.2)
4-6 weeks post-RT 0  (0.1) 0  (0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intensity-Modulated Radiation Therapy, Standard Radiation Therapy
Comments 5 weeks
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.61
Comments [Not Specified]
Method t-test, 2 sided
Comments 2-sided significance level = 0.05
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Intensity-Modulated Radiation Therapy, Standard Radiation Therapy
Comments 4-6 weeks post-RT
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments [Not Specified]
Method t-test, 2 sided
Comments 2-sided significance level = 0.05
7.Secondary Outcome
Title Local-regional Control
Hide Description Local recurrence is defined as a disease in the radiation treatment field. This can include a local vaginal recurrence or nodal disease within the field. Para-aortic recurrence is defined as new lymphadenopathy in the para-aortic distribution. Local-regional control time is defined as time from randomization to the date of local recurrence, last known follow-up (censored), or death (competing risk). Local-regional control rates are estimated using the cumulative incidence method.
Time Frame From randomization to 3 years. (Patients are followed until death or study termination, whichever occurs first.)
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Disease-free Survival
Hide Description Disease (progression) is defined as local recurrence, para-aortic recurrence, or distant metastasis. Local recurrence is defined as a disease in the radiation treatment field. This can include a local vaginal recurrence or nodal disease within the field. Para-aortic recurrence is defined as new lymphadenopathy in the para-aortic distribution. Distant metastasis is defined as involvement of another organ or peritoneal disease. Evidence of distant metastases or new lymphadenopathy on surveillance imaging should be biopsied if possible to document disease recurrence. Disease-free survival time is defined as time from randomization to the date of progression, death, or last known follow-up (censored). Disease-free survival rates are estimated using the Kaplan-Meier method.
Time Frame From randomization to 3 years. (Patients are followed until death or study termination, whichever occurs first.)
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Overall Survival
Hide Description Overall survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.
Time Frame From randomization until 3 years. (Patients are followed until death or study termination, whichever occurs first.)
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Identification of Molecular Predictors of Radiation Toxicity and Novel Circulating Cancer Biomarkers
Hide Description Biomarker data has not yet been obtained and therefore this outcome measure cannot yet be reported
Time Frame Tissue samples will be obtained at the time of diagnosis and during the third week of radiation
Outcome Measure Data Not Reported
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 Intensity-Modulated Radiation Therapy Standard Radiation Therapy
Hide Arm/Group Description Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
All-Cause Mortality
Intensity-Modulated Radiation Therapy Standard Radiation Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intensity-Modulated Radiation Therapy Standard Radiation Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   1/125 (0.80%)   2/144 (1.39%) 
Gastrointestinal disorders     
Abdominal pain * 1  0/125 (0.00%)  1/144 (0.69%) 
Diarrhea * 1  0/125 (0.00%)  1/144 (0.69%) 
Nausea * 1  0/125 (0.00%)  1/144 (0.69%) 
Rectal hemorrhage * 1  0/125 (0.00%)  1/144 (0.69%) 
Infections and infestations     
Device related infection * 1  1/125 (0.80%)  0/144 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Intensity-Modulated Radiation Therapy Standard Radiation Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   121/125 (96.80%)   135/144 (93.75%) 
Blood and lymphatic system disorders     
Anemia * 1  26/125 (20.80%)  17/144 (11.81%) 
Ear and labyrinth disorders     
Tinnitus * 1  7/125 (5.60%)  15/144 (10.42%) 
Eye disorders     
Blurred vision * 1  7/125 (5.60%)  4/144 (2.78%) 
Gastrointestinal disorders     
Abdominal pain * 1  45/125 (36.00%)  54/144 (37.50%) 
Bloating * 1  11/125 (8.80%)  13/144 (9.03%) 
Constipation * 1  26/125 (20.80%)  26/144 (18.06%) 
Diarrhea * 1  96/125 (76.80%)  113/144 (78.47%) 
Dyspepsia * 1  8/125 (6.40%)  8/144 (5.56%) 
Gastrointestinal disorders - Other * 1  8/125 (6.40%)  9/144 (6.25%) 
Nausea * 1  48/125 (38.40%)  61/144 (42.36%) 
Proctitis * 1  10/125 (8.00%)  9/144 (6.25%) 
Rectal pain * 1  11/125 (8.80%)  13/144 (9.03%) 
Vomiting * 1  15/125 (12.00%)  27/144 (18.75%) 
General disorders     
Edema limbs * 1  19/125 (15.20%)  16/144 (11.11%) 
Fatigue * 1  91/125 (72.80%)  94/144 (65.28%) 
Pain * 1  19/125 (15.20%)  20/144 (13.89%) 
Infections and infestations     
Urinary tract infection * 1  12/125 (9.60%)  9/144 (6.25%) 
Injury, poisoning and procedural complications     
Dermatitis radiation * 1  8/125 (6.40%)  16/144 (11.11%) 
Investigations     
Lymphocyte count decreased * 1  14/125 (11.20%)  17/144 (11.81%) 
Neutrophil count decreased * 1  8/125 (6.40%)  8/144 (5.56%) 
Platelet count decreased * 1  11/125 (8.80%)  6/144 (4.17%) 
Weight loss * 1  10/125 (8.00%)  9/144 (6.25%) 
White blood cell decreased * 1  21/125 (16.80%)  16/144 (11.11%) 
Metabolism and nutrition disorders     
Anorexia * 1  26/125 (20.80%)  27/144 (18.75%) 
Hyperglycemia * 1  10/125 (8.00%)  15/144 (10.42%) 
Hypoalbuminemia * 1  8/125 (6.40%)  1/144 (0.69%) 
Hypokalemia * 1  7/125 (5.60%)  5/144 (3.47%) 
Hypomagnesemia * 1  12/125 (9.60%)  5/144 (3.47%) 
Hyponatremia * 1  10/125 (8.00%)  7/144 (4.86%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  7/125 (5.60%)  14/144 (9.72%) 
Generalized muscle weakness * 1  7/125 (5.60%)  8/144 (5.56%) 
Nervous system disorders     
Headache * 1  16/125 (12.80%)  14/144 (9.72%) 
Paresthesia * 1  15/125 (12.00%)  12/144 (8.33%) 
Peripheral sensory neuropathy * 1  8/125 (6.40%)  13/144 (9.03%) 
Psychiatric disorders     
Anxiety * 1  10/125 (8.00%)  11/144 (7.64%) 
Depression * 1  9/125 (7.20%)  11/144 (7.64%) 
Insomnia * 1  11/125 (8.80%)  18/144 (12.50%) 
Renal and urinary disorders     
Cystitis noninfective * 1  9/125 (7.20%)  10/144 (6.94%) 
Renal and urinary disorders - Other * 1  9/125 (7.20%)  8/144 (5.56%) 
Urinary frequency * 1  37/125 (29.60%)  46/144 (31.94%) 
Urinary incontinence * 1  23/125 (18.40%)  21/144 (14.58%) 
Urinary tract pain * 1  12/125 (9.60%)  22/144 (15.28%) 
Urinary urgency * 1  13/125 (10.40%)  24/144 (16.67%) 
Reproductive system and breast disorders     
Pelvic pain * 1  20/125 (16.00%)  30/144 (20.83%) 
Vaginal discharge * 1  7/125 (5.60%)  11/144 (7.64%) 
Vaginal hemorrhage * 1  7/125 (5.60%)  5/144 (3.47%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  11/125 (8.80%)  11/144 (7.64%) 
Dyspnea * 1  16/125 (12.80%)  15/144 (10.42%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  9/125 (7.20%)  11/144 (7.64%) 
Pruritus * 1  8/125 (6.40%)  10/144 (6.94%) 
Vascular disorders     
Hot flashes * 1  12/125 (9.60%)  11/144 (7.64%) 
Hypertension * 1  7/125 (5.60%)  8/144 (5.56%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
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.
Results Point of Contact
Name/Title: Wendy Seiferheld, M.S.
Organization: NRG Oncology
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT01672892     History of Changes
Other Study ID Numbers: RTOG 1203
CDR0000738944
NCI-2012-02001 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: August 23, 2012
First Posted: August 27, 2012
Results First Submitted: October 3, 2017
Results First Posted: January 23, 2018
Last Update Posted: April 24, 2018