Trial Outcomes & Findings for Standard Versus Intensity-Modulated Pelvic Radiation Therapy in Treating Patients With Endometrial or Cervical Cancer (NCT NCT01672892)

Last Updated: 2022-06-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

289 participants

Primary outcome timeframe

Baseline and week 5 of RT

Results posted on

2022-06-15

Participant Flow

Participant milestones

Participant milestones
Measure	Intensity-Modulated Radiation Therapy Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy	Standard Radiation Therapy Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
Overall Study STARTED	137	152
Overall Study Eligible Population	130	149
Overall Study Adverse Event Population	125	144
Overall Study COMPLETED	130	149
Overall Study NOT COMPLETED	7	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Intensity-Modulated Radiation Therapy Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy	Standard Radiation Therapy Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
Overall Study Protocol Violation	7	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intensity-Modulated Radiation Therapy n=129 Participants Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy	Standard Radiation Therapy n=149 Participants Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy	Total n=278 Participants Total of all reporting groups
Age, Continuous	62 years n=93 Participants	61 years n=4 Participants	61 years n=27 Participants
Sex: Female, Male Female	129 Participants n=93 Participants	149 Participants n=4 Participants	278 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline and week 5 of RT

Population: 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.

Outcome measures

Outcome measures
Measure	Intensity-Modulated Radiation Therapy n=107 Participants Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy	Standard Radiation Therapy n=126 Participants Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
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	-18.6 units on a scale Standard Deviation 18.7	-23.6 units on a scale Standard Deviation 19.4

SECONDARY outcome

Timeframe: Baseline to Week 5 of RT

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Intensity-Modulated Radiation Therapy n=122 Participants Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy	Standard Radiation Therapy n=136 Participants Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
Percentage of Patients With Acute Grade 2+ GI Toxicity at 5 Weeks From the Start of Treatment	26.2 percentage of participants Interval 18.4 to 34.4	22.1 percentage of participants Interval 15.1 to 29.0

SECONDARY outcome

Timeframe: Baseline, week 3 and 5 of RT, and 4-6 weeks after RT

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Intensity-Modulated Radiation Therapy n=130 Participants Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy	Standard Radiation Therapy n=149 Participants Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
Urinary Toxicity, as Measured by Change in EPIC Urinary Domain Week 3 of RT	-2.5 score on a scale Standard Deviation 11.3	-6.0 score on a scale Standard Deviation 14.5
Urinary Toxicity, as Measured by Change in EPIC Urinary Domain Week 5 of RT	-5.6 score on a scale Standard Deviation 15.3	-10.4 score on a scale Standard Deviation 17.5
Urinary Toxicity, as Measured by Change in EPIC Urinary Domain 4-6 Weeks Post-RT	-2.7 score on a scale Standard Deviation 13.0	-4.1 score on a scale Standard Deviation 12.1

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Intensity-Modulated Radiation Therapy n=130 Participants Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy	Standard Radiation Therapy n=149 Participants Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
Quality of Life, as Measured by Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) and FACT-Cx (Cervix) Subscale FACT-G total - 5 weeks	-6.4 score on a scale Standard Deviation 12.7	-7.6 score on a scale Standard Deviation 13.4
Quality of Life, as Measured by Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) and FACT-Cx (Cervix) Subscale FACT-G total 4-6 weeks post-RT	-0.2 score on a scale Standard Deviation 11.7	0.5 score on a scale Standard Deviation 13.9
Quality of Life, as Measured by Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) and FACT-Cx (Cervix) Subscale FACT-Cx subscale - 5 weeks	-2.7 score on a scale Standard Deviation 6.1	-4.9 score on a scale Standard Deviation 6.5
Quality of Life, as Measured by Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) and FACT-Cx (Cervix) Subscale FACT-Cx subscale - 4-6 weeks post-RT	-0.3 score on a scale Standard Deviation 5.7	0.4 score on a scale Standard Deviation 5.7
Quality of Life, as Measured by Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) and FACT-Cx (Cervix) Subscale Physical subscale - 5 weeks	-4.2 score on a scale Standard Deviation 6.0	-6.1 score on a scale Standard Deviation 6.1
Quality of Life, as Measured by Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) and FACT-Cx (Cervix) Subscale Physical - subscale - 4-6 weeks post-RT	-1.1 score on a scale Standard Deviation 4.9	-1.2 score on a scale Standard Deviation 4.8
Quality of Life, as Measured by Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) and FACT-Cx (Cervix) Subscale Functional subscale - 5 weeks	-2.1 score on a scale Standard Deviation 5.7	-1.6 score on a scale Standard Deviation 5.9
Quality of Life, as Measured by Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) and FACT-Cx (Cervix) Subscale Functional - subscale - 4-6 weeks post-RT	-0.1 score on a scale Standard Deviation 5.0	0.6 score on a scale Standard Deviation 5.4
Quality of Life, as Measured by Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) and FACT-Cx (Cervix) Subscale Emotional subscale - 5 weeks	0.7 score on a scale Standard Deviation 3.5	0.9 score on a scale Standard Deviation 3.7
Quality of Life, as Measured by Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) and FACT-Cx (Cervix) Subscale Emotional subscale - 4-6 weeks post-RT	1.1 score on a scale Standard Deviation 3.1	1.9 score on a scale Standard Deviation 3.7
Quality of Life, as Measured by Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) and FACT-Cx (Cervix) Subscale Social subscale - 5 weeks	-0.9 score on a scale Standard Deviation 5.4	-0.6 score on a scale Standard Deviation 5.2
Quality of Life, as Measured by Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) and FACT-Cx (Cervix) Subscale Social subscale - 4-6 weeks post-RT	0.0 score on a scale Standard Deviation 4.8	-0.8 score on a scale Standard Deviation 6.4

SECONDARY outcome

Timeframe: Baseline, week 5 of RT, 4-6 weeks after RT

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Intensity-Modulated Radiation Therapy n=130 Participants Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy	Standard Radiation Therapy n=149 Participants Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
Health Utilities, as Measured by Change From Baseline in EQ-5D 5 weeks	0 score on a scale Standard Deviation 0.2	0 score on a scale Standard Deviation 0.2
Health Utilities, as Measured by Change From Baseline in EQ-5D 4-6 weeks post-RT	0 score on a scale Standard Deviation 0.1	0 score on a scale Standard Deviation 0.1

SECONDARY outcome

Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months.

Population: Eligible participants \[later analysis\]

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.

Outcome measures

Outcome measures
Measure	Intensity-Modulated Radiation Therapy n=130 Participants Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy	Standard Radiation Therapy n=149 Participants Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
Local-regional Recurrence	3.5 percentage of participants Interval 1.1 to 8.1	2.2 percentage of participants Interval 0.6 to 5.7

SECONDARY outcome

Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months.

Population: Eligible participants \[later analysis\]

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.

Outcome measures

Outcome measures
Measure	Intensity-Modulated Radiation Therapy n=130 Participants Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy	Standard Radiation Therapy n=149 Participants Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
Disease-free Survival	85.5 percentage of participants Interval 79.2 to 91.9	80.8 percentage of participants Interval 74.2 to 87.3

SECONDARY outcome

Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months.

Population: Eligible participants \[later analysis\]

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.

Outcome measures

Outcome measures
Measure	Intensity-Modulated Radiation Therapy n=130 Participants Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy	Standard Radiation Therapy n=149 Participants Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
Overall Survival	92.4 percentage of participants Interval 87.7 to 97.2	97.0 percentage of participants Interval 94.1 to 99.9

SECONDARY outcome

Timeframe: Outcome measure will not be analyzed

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and week 5 of RT

Population: 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. \[later analysis\]

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.

Outcome measures

Outcome measures
Measure	Intensity-Modulated Radiation Therapy n=279 Participants Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy	Standard Radiation Therapy Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
Standardized Cronbach's Alpha for EPIC Bowel and Urinary Domains (Validation - Internal Consistency Reliability) Bowel Domain Baseline	0.77 standard deviation	—
Standardized Cronbach's Alpha for EPIC Bowel and Urinary Domains (Validation - Internal Consistency Reliability) Bowel Domain Week 5	0.89 standard deviation	—
Standardized Cronbach's Alpha for EPIC Bowel and Urinary Domains (Validation - Internal Consistency Reliability) Urinary Domain Baseline	0.84 standard deviation	—
Standardized Cronbach's Alpha for EPIC Bowel and Urinary Domains (Validation - Internal Consistency Reliability) Urinary Domain Week 5	0.89 standard deviation	—

SECONDARY outcome

Timeframe: Baseline and week 5 of RT

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.

Outcome measures

Outcome measures
Measure	Intensity-Modulated Radiation Therapy n=279 Participants Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy	Standard Radiation Therapy Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
Spearman's Correlation Coefficient for EPIC Bowel Domain vs. Urinary Domains (Validation - Conceptual Independence) Baseline	0.41 correlation coefficient	—
Spearman's Correlation Coefficient for EPIC Bowel Domain vs. Urinary Domains (Validation - Conceptual Independence) Week 5	0.45 correlation coefficient	—

SECONDARY outcome

Timeframe: Baseline and week 5 of RT

Population: 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. \[later analysis\]

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.

Outcome measures

Outcome measures
Measure	Intensity-Modulated Radiation Therapy n=279 Participants Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy	Standard Radiation Therapy Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
Pearson Correlation Coefficient for EPIC Bowel and Urinary Domains vs. FACT-G Total Score (Validation - Criterion Validity) Bowel Baseline	0.44 correlation coefficient	—
Pearson Correlation Coefficient for EPIC Bowel and Urinary Domains vs. FACT-G Total Score (Validation - Criterion Validity) Bowel Week 5	0.44 correlation coefficient	—
Pearson Correlation Coefficient for EPIC Bowel and Urinary Domains vs. FACT-G Total Score (Validation - Criterion Validity) Urinary Baseline	0.39 correlation coefficient	—
Pearson Correlation Coefficient for EPIC Bowel and Urinary Domains vs. FACT-G Total Score (Validation - Criterion Validity) Urinary Week 5	0.43 correlation coefficient	—

SECONDARY outcome

Timeframe: Baseline and week 5 of RT

Population: 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. \[later analysis\]

Outcome measures

Outcome measures
Measure	Intensity-Modulated Radiation Therapy n=279 Participants Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy	Standard Radiation Therapy Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
Mean Change From Baseline in EPIC Bowel and Urinary Domain (Validation - Sensitivity to Treatment) Bowel Domain	21.37 score on a scale Standard Deviation 19.11	—
Mean Change From Baseline in EPIC Bowel and Urinary Domain (Validation - Sensitivity to Treatment) Urinary Domain	8.11 score on a scale Standard Deviation 16.98	—

Adverse Events

Intensity-Modulated Radiation Therapy

Serious events: 1 serious events

Other events: 122 other events

Deaths: 0 deaths

Standard Radiation Therapy

Serious events: 2 serious events

Other events: 136 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Intensity-Modulated Radiation Therapy n=125 participants at risk Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy	Standard Radiation Therapy n=144 participants at risk Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
Gastrointestinal disorders Abdominal pain	0.00% 0/125 • From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months. [Later analysis] Eligible participants with adverse event data. (With the longer follow-up, adverse event data was collected from more participants compared to outcome measure 2. )	0.69% 1/144 • From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months. [Later analysis] Eligible participants with adverse event data. (With the longer follow-up, adverse event data was collected from more participants compared to outcome measure 2. )
Gastrointestinal disorders Diarrhea	0.00% 0/125 • From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months. [Later analysis] Eligible participants with adverse event data. (With the longer follow-up, adverse event data was collected from more participants compared to outcome measure 2. )	0.69% 1/144 • From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months. [Later analysis] Eligible participants with adverse event data. (With the longer follow-up, adverse event data was collected from more participants compared to outcome measure 2. )
Gastrointestinal disorders Nausea	0.00% 0/125 • From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months. [Later analysis] Eligible participants with adverse event data. (With the longer follow-up, adverse event data was collected from more participants compared to outcome measure 2. )	0.69% 1/144 • From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months. [Later analysis] Eligible participants with adverse event data. (With the longer follow-up, adverse event data was collected from more participants compared to outcome measure 2. )
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/125 • From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months. [Later analysis] Eligible participants with adverse event data. (With the longer follow-up, adverse event data was collected from more participants compared to outcome measure 2. )	0.69% 1/144 • From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months. [Later analysis] Eligible participants with adverse event data. (With the longer follow-up, adverse event data was collected from more participants compared to outcome measure 2. )
Infections and infestations Device related infection	0.80% 1/125 • From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months. [Later analysis] Eligible participants with adverse event data. (With the longer follow-up, adverse event data was collected from more participants compared to outcome measure 2. )	0.00% 0/144 • From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months. [Later analysis] Eligible participants with adverse event data. (With the longer follow-up, adverse event data was collected from more participants compared to outcome measure 2. )

Other adverse events

Additional Information

Wendy Seiferheld, M.S.

NRG Oncology

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
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Restriction type: OTHER