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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 : June 30, 2020
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
Eligible Population 130 149
Adverse Event Population [1] 125 144
Completed [2] 130 149
Not Completed 7 3
Reason Not Completed
Protocol Violation             7             3
[1]
Eligible participants with adverse event data collected anytime during the study.
[2]
Participants contributing data to any results are considered to have completed the study.
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
Hide Outcome Measure Data
Hide Analysis Population Description
Questionnaires were not completed by all eligible participants. Therefore, only 107/130 had data at both baseline and week 5 on the Intensity-Modulated Radiation Therapy arm, and only 126/149 had data at both baseline and week 5 on the Standard Radiation Therapy arm.
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)
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 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
Hide Outcome Measure Data
Hide Analysis Population Description
Adverse event data was not obtained from all eligible participants at 5 weeks from treatment start. Therefore, only 122/130 had data on the Intensity-Modulated Radiation Therapy arm, and only 136/149 had data at on the Standard Radiation Therapy arm.
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)
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
3.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
Hide Outcome Measure Data
Hide Analysis Population Description
Questionnaires were not completed by all eligible participants. Therefore, data was only collected from: Arm A- 110/130 at baseline and week 3, 107/130 at baseline and week 5, 99/130 at baseline and 4-6 weeks; Arm B- 127/149 at baseline and week 3, 126/149 at baseline and week 5, 121/149 at baseline and 4-6 week.
Arm/Group Title Intensity-Modulated Radiation Therapy (A) Standard Radiation Therapy (B)
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 130 149
Mean (Standard Deviation)
Unit of Measure: score 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)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intensity-Modulated Radiation Therapy (A), Standard Radiation Therapy (B)
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
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Intensity-Modulated Radiation Therapy (A), Standard Radiation Therapy (B)
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
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Intensity-Modulated Radiation Therapy (A), Standard Radiation Therapy (B)
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
4.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
Hide Outcome Measure Data
Hide Analysis Population Description
Questionnaires were not completed by all eligible participants. Therefore, the number of participants reported below are the number with the relevant questions answered at baseline and the given time point on each arm.
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 130 149
Mean (Standard Deviation)
Unit of Measure: score 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)
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
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
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
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
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
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
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
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
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
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
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
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
5.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
Hide Outcome Measure Data
Hide Analysis Population Description
Questionnaires were not completed by all eligible participants. Therefore, data was only collected from: Intensity-Modulated Radiation Therapy arm: 78/130 at baseline and week 5, 74/130 at baseline and 4-6 weeks post-RT; Standard Radiation Therapy arm: 91/149 at baseline and week 5, 89/149 at baseline and 4-6 weeks post-RT.
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 130 149
Mean (Standard Deviation)
Unit of Measure: score on a scale
5 weeks Number Analyzed 78 participants 91 participants
0  (0.2) 0  (0.2)
4-6 weeks post-RT Number Analyzed 74 participants 89 participants
0  (0.1) 0  (0.1)
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
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
6.Secondary Outcome
Title Local-regional Recurrence
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 recurrence rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year rates are provided. Analysis occurred after all patients had been on study for at least 3 years.
Time Frame From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants [later analysis]
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 130 149
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
3.5
(1.1 to 8.1)
2.2
(0.6 to 5.7)
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 0.81
Comments [Not Specified]
Method Gray's test
Comments Two-sided significance level = 0.05
7.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. 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. 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. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year rates are provided. Analysis occurred after all patients had been on study for at least 3 years.
Time Frame From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants [later analysis]
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 130 149
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
85.5
(79.2 to 91.9)
80.8
(74.2 to 87.3)
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 0.21
Comments [Not Specified]
Method Log Rank
Comments Two-side significance level = 0.05
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.39
Confidence Interval (2-Sided) 95%
0.82 to 2.35
Estimation Comments Reference level = Intensity-Modulated Radiation Therapy
8.Secondary Outcome
Title Overall Survival
Hide Description Overall survival time is defined as time from registration/randomization to the date of death from any cause or last known follow-up (censored). Survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year rates are provided. Analysis occurred after all patients had been on study for at least 3 years.
Time Frame From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants [later analysis]
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 130 149
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
92.4
(87.7 to 97.2)
97.0
(94.1 to 99.9)
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 0.53
Comments [Not Specified]
Method Log Rank
Comments Two-sided significance level = 0.05
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.76
Confidence Interval (2-Sided) 95%
0.32 to 1.79
Estimation Comments Reference level = Intensity-Modulated Radiation Therapy
9.Secondary Outcome
Title Identification of Molecular Predictors of Radiation Toxicity and Novel Circulating Cancer Biomarkers
Hide Description [Not Specified]
Time Frame Outcome measure will not be analyzed
Hide Outcome Measure Data
Hide Analysis Population Description
The protocol did not provide sufficient detail to meet National Cancer Institute requirements for release of specimens from the NRG tissue bank for the protocol-specified analysis, therefore no assays were performed and no data were collected for this outcome measure. Specimen use will require federal approval and funding separate from this trial.
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 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Standardized Cronbach's Alpha for EPIC Bowel and Urinary Domains (Validation - Internal Consistency Reliability)
Hide Description The EPIC bowel domain consists of 14 items and has a function subscale (7 items) and bother subscale (7 items). The EPIC urinary domain consists of 12 total items and 4 subscales, functional (5 items), bother (7), incontinence (4) and irritative/obstructive (7). For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life. A domain score is the average of the transformed item scores. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Cronbach's alpha is an internal consistency estimate of reliability of psychometric test scores and is a function of the number of items in a test, the average covariance between item-pairs, and the variance of the total score. An alpha of 0.60-0.79 was to be considered acceptable reliability; higher than 0.8 was to be considered good reliability.
Time Frame Baseline and week 5 of RT
Hide Outcome Measure Data
Hide Analysis Population Description
Questionnaires were not completed by all eligible participants. Therefore, for both domains data was only collected from: 277/279 (arms combined) at baseline, 241/279 at week 5. [later analysis]
Arm/Group Title All Participants
Hide Arm/Group Description:
Participants from both treatment arms combined.
Overall Number of Participants Analyzed 279
Measure Type: Number
Unit of Measure: standard deviation
Bowel Domain Baseline Number Analyzed 277 participants
0.77
Bowel Domain Week 5 Number Analyzed 241 participants
0.89
Urinary Domain Baseline Number Analyzed 277 participants
0.84
Urinary Domain Week 5 Number Analyzed 241 participants
0.89
11.Secondary Outcome
Title Spearman's Correlation Coefficient for EPIC Bowel Domain vs. Urinary Domains (Validation - Conceptual Independence)
Hide Description The EPIC bowel domain consists of 14 items and has a function subscale (7 items) and bother subscale (7 items). The EPIC urinary domain consists of 12 total items and 4 subscales, functional (5 items), bother (7), incontinence (4) and irritative/obstructive (7). For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life. A domain score is the average of the transformed item scores. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Spearman's rank correlation coefficient is a nonparametric measure of rank correlation between two variables with a value between +1 and -1, where 1 is total positive rank correlation, 0 is no rank correlation, and -1 is total negative rank correlation.
Time Frame Baseline and week 5 of RT
Hide Outcome Measure Data
Hide Analysis Population Description
Questionnaires were not completed by all eligible participants. Therefore, for both domains data was only collected from: 277/279 (arms combined) at baseline, 241/279 at week 5. [later analysis]
Arm/Group Title All Participants
Hide Arm/Group Description:
Participants from both treatment arms combined.
Overall Number of Participants Analyzed 279
Measure Type: Number
Unit of Measure: correlation coefficient
Baseline Number Analyzed 277 participants
0.41
Week 5 Number Analyzed 241 participants
0.45
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments Baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method nonparametric one-sample t-test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection All Participants
Comments Week 5
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method nonparametric one-sample t-test
Comments [Not Specified]
12.Secondary Outcome
Title Pearson Correlation Coefficient for EPIC Bowel and Urinary Domains vs. FACT-G Total Score (Validation - Criterion Validity)
Hide Description The EPIC bowel domain and urinary domains consist of 14 and 12 items, respectively. For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life (QOL). A domain score is the average of the transformed item scores. At least 80% of the items in a domain must be completed in order to compute the score. The FACT-G is 27-item measure. Higher scores represent higher QOL. Each item has 5 responses options, 0=Not a lot and 4=Very much. Items are added together for the total score, ranging from 0-108. Certain items must be reversed before adding by subtracting the response from 4. The Pearson correlation coefficient is a measure of the linear correlation between two variables with a value between +1 and -1, where 1 is total positive linear correlation, 0 is no linear correlation, and -1 is total negative linear correlation.
Time Frame Baseline and week 5 of RT
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with baseline EPIC and FACT-G scores [later analysis] Questionnaires were not completed by all eligible participants. Therefore, for both domains only 231/279 (arms combined) participants had both FACT-G and EPIC data at baseline, and 199/279 participants had both FACT-G and EPIC data at week 5. [later analysis]
Arm/Group Title All Participants
Hide Arm/Group Description:
Participants from both treatment arms combined.
Overall Number of Participants Analyzed 279
Measure Type: Number
Unit of Measure: correlation coefficient
Bowel Baseline Number Analyzed 231 participants
0.44
Bowel Week 5 Number Analyzed 199 participants
0.44
Urinary Baseline Number Analyzed 231 participants
0.39
Urinary Week 5 Number Analyzed 199 participants
0.43
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments Bowel domain at baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method One-sample t-test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection All Participants
Comments Bowel domain at week 5
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method One-sample t-test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection All Participants
Comments Urinary domain at baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method One-sample t-test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection All Participants
Comments Urinary domain at week 5
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method One-sample t-test
Comments [Not Specified]
13.Secondary Outcome
Title Mean Change From Baseline in EPIC Bowel and Urinary Domain (Validation - Sensitivity to Treatment)
Hide Description

The EPIC bowel domain and urinary domains consist of 14 and 12 items, respectively. For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life (QOL). A domain score is the average of the transformed item scores. At least 80% of the items in a domain must be completed in order to compute the score. Difference is calculated as baseline - week 5.

A positive change score represents a decline in function.

Time Frame Baseline and week 5 of RT
Hide Outcome Measure Data
Hide Analysis Population Description
Questionnaires were not completed by all eligible participants. Therefore, for both domains only 234/279 (arms combined) participants had data at both baseline and week 5. [later analysis]
Arm/Group Title All Participants
Hide Arm/Group Description:
Participants from both treatment arms combined.
Overall Number of Participants Analyzed 279
Mean (Standard Deviation)
Unit of Measure: score on a scale
Bowel Domain Number Analyzed 234 participants
21.37  (19.11)
Urinary Domain Number Analyzed 234 participants
8.11  (16.98)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments Bowel domain
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection All Participants
Comments Urinary domain
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
Time Frame From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months. [Later analysis]
Adverse Event Reporting Description Eligible participants with adverse event data. (With the longer follow-up, adverse event data was collected from more participants compared to outcome measure 2. )
 
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   --/--   --/-- 
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)
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   122/125 (97.60%)   136/144 (94.44%) 
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  46/125 (36.80%)  57/144 (39.58%) 
Bloating * 1  12/125 (9.60%)  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  10/125 (8.00%)  10/144 (6.94%) 
Nausea * 1  49/125 (39.20%)  62/144 (43.06%) 
Proctitis * 1  10/125 (8.00%)  9/144 (6.25%) 
Rectal hemorrhage * 1  5/125 (4.00%)  10/144 (6.94%) 
Rectal pain * 1  11/125 (8.80%)  13/144 (9.03%) 
Vomiting * 1  16/125 (12.80%)  28/144 (19.44%) 
General disorders     
Edema limbs * 1  20/125 (16.00%)  17/144 (11.81%) 
Fatigue * 1  91/125 (72.80%)  94/144 (65.28%) 
Pain * 1  20/125 (16.00%)  20/144 (13.89%) 
Infections and infestations     
Urinary tract infection * 1  13/125 (10.40%)  10/144 (6.94%) 
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%)  16/144 (11.11%) 
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     
Arthralgia * 1  4/125 (3.20%)  8/144 (5.56%) 
Back pain * 1  8/125 (6.40%)  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%)  12/144 (8.33%) 
Depression * 1  9/125 (7.20%)  12/144 (8.33%) 
Insomnia * 1  12/125 (9.60%)  19/144 (13.19%) 
Renal and urinary disorders     
Cystitis noninfective * 1  9/125 (7.20%)  10/144 (6.94%) 
Renal and urinary disorders - Other * 1  10/125 (8.00%)  8/144 (5.56%) 
Urinary frequency * 1  37/125 (29.60%)  48/144 (33.33%) 
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  22/125 (17.60%)  30/144 (20.83%) 
Vaginal discharge * 1  7/125 (5.60%)  11/144 (7.64%) 
Vaginal hemorrhage * 1  8/125 (6.40%)  5/144 (3.47%) 
Vaginal pain * 1  1/125 (0.80%)  8/144 (5.56%) 
Vaginal stricture * 1  4/125 (3.20%)  8/144 (5.56%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  12/125 (9.60%)  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%)  12/144 (8.33%) 
Pruritus * 1  8/125 (6.40%)  10/144 (6.94%) 
Skin and subcutaneous tissue disorders - Other * 1  3/125 (2.40%)  14/144 (9.72%) 
Vascular disorders     
Hot flashes * 1  13/125 (10.40%)  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)
Some outcome measures were analyzed at a later time ("[later analysis]") and included a patient initially considered to be ineligible (protocol violation), but later deemed eligible, thus resulting in an additional participant for these results.
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
Layout table for Results Point of Contact information
Name/Title: Wendy Seiferheld, M.S.
Organization: NRG Oncology
EMail: seiferheldw@nrgoncology.org
Layout table for additonal information
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT01672892    
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: June 30, 2020