Trial Outcomes & Findings for Radiation Therapy in Treating Patients With Stage II Prostate Cancer (NCT NCT00331773)

NCT ID: NCT00331773

Last Updated: 2023-01-18

Results Overview

Five-year rates are estimated by the Kaplan-Meier method. DFS events included local progression, distant metastatic progression, biochemical recurrence as defined by the Radiation Therapy Oncology Group (RTOG) Phoenix definition, or death from any cause. Patients who experienced second primary cancers remained under observation for DFS events.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1116 participants
• Primary outcome timeframe: Analysis occurs after all patients have been followed for five years.
• Results posted on: 2023-01-18

Participant Flow

Participant milestones

Measure	Conventional 3D-CRT Conventional 3D-CRT or intensity-modulated radiotherapy (IMRT): Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy	Hypofractionated 3D-CRT Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
Overall Study STARTED	558	557
Overall Study COMPLETED	542	550
Overall Study NOT COMPLETED	16	7

Reasons for withdrawal

Measure	Conventional 3D-CRT Conventional 3D-CRT or intensity-modulated radiotherapy (IMRT): Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy	Hypofractionated 3D-CRT Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
Overall Study Withdrawal by Subject	6	4
Overall Study Protocol Violation	10	3

Baseline Characteristics

Radiation Therapy in Treating Patients With Stage II Prostate Cancer

Baseline characteristics by cohort

Measure	Conventional 3D-CRT n=542 Participants Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy	Hypofractionated 3D-CRT n=550 Participants Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.	Total n=1092 Participants Total of all reporting groups
Age, Continuous	67 years n=5 Participants	67 years n=7 Participants	67 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	542 Participants n=5 Participants	550 Participants n=7 Participants	1092 Participants n=5 Participants

PRIMARY outcome

Timeframe: Analysis occurs after all patients have been followed for five years.

Population: Eligible patients who did not withdraw consent

Five-year rates are estimated by the Kaplan-Meier method. DFS events included local progression, distant metastatic progression, biochemical recurrence as defined by the Radiation Therapy Oncology Group (RTOG) Phoenix definition, or death from any cause. Patients who experienced second primary cancers remained under observation for DFS events.

Outcome measures

Measure	Conventional 3D-CRT n=542 Participants Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy	Hypofractionated 3D-CRT n=550 Participants Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
Five-year Disease-free Survival (DFS) Rate	85.3 percentage of participants Interval 81.9 to 88.1	86.3 percentage of participants Interval 83.1 to 89.0

SECONDARY outcome

Timeframe: Analysis occurs after all patients have been followed for five years.

Population: All eligible patients.

Clinical criteria for local recurrence are progression (increase in palpable abnormality) at any time, failure of regression of the palpable tumor by 2 years, and redevelopment of a palpable abnormality after complete disappearance of previous abnormalities. Histologic criteria for local recurrence are presence of prostatic carcinoma upon biopsy and positive biopsy of the palpably normal prostate more than 2 years after the start of treatment. The arms were not statistically compared because of an insufficient number of events.

Outcome measures

Measure	Conventional 3D-CRT n=542 Participants Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy	Hypofractionated 3D-CRT n=550 Participants Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
Five-year Local Progression Rate	1.2 percentage of participants Interval 0.5 to 2.4	0.4 percentage of participants Interval 0.1 to 1.3

SECONDARY outcome

Timeframe: Analysis occurs after all patients have been followed for five years.

Population: All eligible patients

An event was death in association with any of the following conditions:

• Primary cause of death certified as due to prostate cancer
• Further clinical tumor progression occurring after initiation of "salvage" anti-tumor (e.g., (androgen suppression) therapy
• A rise (that exceeds 1.0 ng/mL) in the serum prostate-specific antigen (PSA) level on at least two consecutive occasions that occurs during or after "salvage" androgen suppression therapy
• Disease progression in the absence of any anti-tumor therapy
• Death from a complication of therapy, irrespective of disease status. The arms were not statistically compared because of an insufficient number of events.

Outcome measures

Measure	Conventional 3D-CRT n=542 Participants Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy	Hypofractionated 3D-CRT n=550 Participants Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
Five-year Disease-specific Survival Rate	0.2 percentage of participants Interval 0.0 to 1.0	0.2 percentage of participants Interval 0.1 to 1.1

SECONDARY outcome

Timeframe: Analysis occurs after all patients have been followed for five years.

Population: Eligible patients who did not withdraw consent.

Five-year rates are shown (cumulative incidence estimates). Note, although the protocol calls this endpoint "Freedom from biochemical recurrence", it defines the endpoint as "The time to PSA failure". An event for PSA, i.e. biochemical, failure was the first of the following: initiation of non-protocol (e.g., salvage) hormone therapy, or an increase in PSA of at least 2 ng/mL. Time to biochemical failure was measured from study entry until the date of failure.

Outcome measures

Measure	Conventional 3D-CRT n=542 Participants Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy	Hypofractionated 3D-CRT n=550 Participants Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
Five-year PSA Failure Rate	8.1 percentage of participants Interval 5.9 to 10.6	6.3 percentage of participants Interval 4.5 to 8.6

SECONDARY outcome

Timeframe: Analysis occurs after all patients have been followed for five years.

Population: Eligible patients who did not withdraw consent.

Five-year rates Kaplan-Meier estimates. Overall survival (OS) was measured from study entry until the date of death. Patients still alive at the time of analysis were censored at the date of last follow-up

Outcome measures

Measure	Conventional 3D-CRT n=542 Participants Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy	Hypofractionated 3D-CRT n=550 Participants Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
Five-year Overall Survival Rate	93.2 percentage of participants Interval 90.7 to 95.1	92.5 percentage of participants Interval 89.9 to 94.5

SECONDARY outcome

Timeframe: Acute toxicity is measured from start of treatment to 90 days from the completion of treatment. Late toxicity is defined as toxicity occuring after 90 days from completion of treatment. Analysis occured at the time of the primary endpoint analysis.

Population: All eligible patients who started study treatment and did not withdraw consent

The frequency of genitourinary (GU) and gastrointestinal (GI) adverse events as defined and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 3) were compared between treatment arms. Acute toxicity was defined as any toxicity beginning within 90 days of completion of RT, and late toxicity was defined as any toxicity beginning more than 90 days after the completion of RT. Acute and late GU and GI toxicity rates were tabulated and reported in two ways: dichotomized as < grade 2 vs ≥ grade 2, and dichotomized as < grade 3 vs ≥ grade 3. Higher grade indicates more severity.

Outcome measures

Measure	Conventional 3D-CRT n=534 Participants Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy	Hypofractionated 3D-CRT n=545 Participants Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
Frequency of Patients With GU and GI Acute and Late Toxicity Acute GI: Grade >= 2:	55 participants	58 participants
Frequency of Patients With GU and GI Acute and Late Toxicity Acute GI: Grade >= 3	3 participants	4 participants
Frequency of Patients With GU and GI Acute and Late Toxicity Acute GU: Grade >= 2	145 participants	147 participants
Frequency of Patients With GU and GI Acute and Late Toxicity Acute GU: Grade >= 3	13 participants	18 participants
Frequency of Patients With GU and GI Acute and Late Toxicity Late GI: Grade >= 2	75 participants	121 participants
Frequency of Patients With GU and GI Acute and Late Toxicity Late GI: Grade >= 3	14 participants	22 participants
Frequency of Patients With GU and GI Acute and Late Toxicity Late GU: Grade >= 2	121 participants	161 participants
Frequency of Patients With GU and GI Acute and Late Toxicity Late GU: Grade >= 3	12 participants	19 participants

SECONDARY outcome

Timeframe: Baseline, 6, 12, and 24 months, and 5 years

Population: Eligible patients with both a baseline and follow-up EPIC domain score, who did not withdraw consent

Prostate cancer (PC) Health-Related Quality of Life (HRQOL) outcomes as measured by change over time in the Expanded Prostate Cancer Index Composite [EPIC], a PC HRQOL instrument measuring a broad spectrum of urinary, bowel, and sexual symptoms related to radiotherapy, is compared between arms. The EPIC questionnaire was grouped into four domains (bowel, urinary, sexual, hormonal), each with a score ranging from 0 (worst) to 100 (best), and was assessed at baseline, 6, 12, and 24 months, and 5 years. The difference in score from baseline to each time point was calculated and the Wilcoxon test statistic was used to test the null hypothesis that responses are the same across the two treatment arms vs. the alternative hypothesis that they are different, using a 2-sided alpha of 0.05 at each timepoint, resulting in an alpha of 0.0125 for each domain. Each row refers to a separate analysis.

Outcome measures

Measure	Conventional 3D-CRT n=542 Participants Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy	Hypofractionated 3D-CRT n=550 Participants Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
Comparison of Disease-specific HRQOL Change in Expanded Prostate Cancer Index Composite (EPIC); the Utilization of Sexual Medications/Devices Supplements the EPIC 24 mo. EPIC Hormonal Domain	-2.4 units on a scale Standard Deviation 9.5	-1.7 units on a scale Standard Deviation 10.5
Comparison of Disease-specific HRQOL Change in Expanded Prostate Cancer Index Composite (EPIC); the Utilization of Sexual Medications/Devices Supplements the EPIC 60 mo. EPIC Hormonal Domain	-2.1 units on a scale Standard Deviation 10.3	-2.1 units on a scale Standard Deviation 10.4
Comparison of Disease-specific HRQOL Change in Expanded Prostate Cancer Index Composite (EPIC); the Utilization of Sexual Medications/Devices Supplements the EPIC 6 mo. EPIC Bowel Domain	-4 units on a scale Standard Deviation 12.1	-3.7 units on a scale Standard Deviation 11.7
Comparison of Disease-specific HRQOL Change in Expanded Prostate Cancer Index Composite (EPIC); the Utilization of Sexual Medications/Devices Supplements the EPIC 6 mo. EPIC Urinary Domain	0 units on a scale Standard Deviation 10.5	-1.5 units on a scale Standard Deviation 11.9
Comparison of Disease-specific HRQOL Change in Expanded Prostate Cancer Index Composite (EPIC); the Utilization of Sexual Medications/Devices Supplements the EPIC 6 mo. EPIC Sexual Domain	-8.1 units on a scale Standard Deviation 20.9	-7.8 units on a scale Standard Deviation 17.8
Comparison of Disease-specific HRQOL Change in Expanded Prostate Cancer Index Composite (EPIC); the Utilization of Sexual Medications/Devices Supplements the EPIC 6 mo. EPIC Hormonal Domain	-2.4 units on a scale Standard Deviation 10.5	-1.8 units on a scale Standard Deviation 10
Comparison of Disease-specific HRQOL Change in Expanded Prostate Cancer Index Composite (EPIC); the Utilization of Sexual Medications/Devices Supplements the EPIC 12 mo. EPIC Bowel Domain (n=273, 294)	-3.7 units on a scale Standard Deviation 11.4	-7.5 units on a scale Standard Deviation 14.6
Comparison of Disease-specific HRQOL Change in Expanded Prostate Cancer Index Composite (EPIC); the Utilization of Sexual Medications/Devices Supplements the EPIC 12 mo. EPIC Urinary Domain	-0.3 units on a scale Standard Deviation 10.4	-1.8 units on a scale Standard Deviation 13.1
Comparison of Disease-specific HRQOL Change in Expanded Prostate Cancer Index Composite (EPIC); the Utilization of Sexual Medications/Devices Supplements the EPIC 12 mo. EPIC Sexual Domain	-8.1 units on a scale Standard Deviation 19.7	-8.4 units on a scale Standard Deviation 20
Comparison of Disease-specific HRQOL Change in Expanded Prostate Cancer Index Composite (EPIC); the Utilization of Sexual Medications/Devices Supplements the EPIC 12 mo. EPIC Hormonal Domain	-1.6 units on a scale Standard Deviation 8.5	-1.6 units on a scale Standard Deviation 9.4
Comparison of Disease-specific HRQOL Change in Expanded Prostate Cancer Index Composite (EPIC); the Utilization of Sexual Medications/Devices Supplements the EPIC 24 mo. EPIC Bowel Domain	-4.4 units on a scale Standard Deviation 12.4	-6 units on a scale Standard Deviation 12.7
Comparison of Disease-specific HRQOL Change in Expanded Prostate Cancer Index Composite (EPIC); the Utilization of Sexual Medications/Devices Supplements the EPIC 24 mo. EPIC Urinary Domain	-0.5 units on a scale Standard Deviation 10.6	-0.7 units on a scale Standard Deviation 12.4
Comparison of Disease-specific HRQOL Change in Expanded Prostate Cancer Index Composite (EPIC); the Utilization of Sexual Medications/Devices Supplements the EPIC 24 mo. EPIC Sexual Domain	-9.7 units on a scale Standard Deviation 21.1	-10.4 units on a scale Standard Deviation 21
Comparison of Disease-specific HRQOL Change in Expanded Prostate Cancer Index Composite (EPIC); the Utilization of Sexual Medications/Devices Supplements the EPIC 60 mo. EPIC Bowel Domain	-3.6 units on a scale Standard Deviation 11.8	-5.2 units on a scale Standard Deviation 12.6
Comparison of Disease-specific HRQOL Change in Expanded Prostate Cancer Index Composite (EPIC); the Utilization of Sexual Medications/Devices Supplements the EPIC 60 mo. EPIC Urinary Domain	-1.2 units on a scale Standard Deviation 12.4	-3.1 units on a scale Standard Deviation 15
Comparison of Disease-specific HRQOL Change in Expanded Prostate Cancer Index Composite (EPIC); the Utilization of Sexual Medications/Devices Supplements the EPIC 60 mo. EPIC Sexual Domain	-13.5 units on a scale Standard Deviation 22.1	-15.7 units on a scale Standard Deviation 24.4

SECONDARY outcome

Timeframe: Baseline, 6, 12, and 24 months, and 5 years

Population: Eligible patients answering the questionaire, who did not withdraw consent

The Utilization of Sexual Medications/Devices questionaire is designed to assess the use of erectile aids among patients treated for prostate cancer. This instrument is used to complement the sexual symptom domain in the EPIC. The percentage of "Yes" responses to the following questions are reported: "Do you have a penile prosthesis", "Have you used an medications or devices to aid or improve erections?".

Outcome measures

Measure	Conventional 3D-CRT n=478 Participants Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy	Hypofractionated 3D-CRT n=484 Participants Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
The Utilization of Sexual Medications/Devices Questionaire 12 mo. medications/devices question	29.6 percentage of participants	30.3 percentage of participants
The Utilization of Sexual Medications/Devices Questionaire 24 mo. penile prosthesis question	1.5 percentage of participants	0 percentage of participants
The Utilization of Sexual Medications/Devices Questionaire 24 mo. medications/devices question	36.3 percentage of participants	33.3 percentage of participants
The Utilization of Sexual Medications/Devices Questionaire 60 mo. penile prosthesis question	1.7 percentage of participants	1.2 percentage of participants
The Utilization of Sexual Medications/Devices Questionaire 60 mo. medications/devices question	35.2 percentage of participants	31.7 percentage of participants
The Utilization of Sexual Medications/Devices Questionaire Baseline penile prosthesis question	2.0 percentage of participants	0.0 percentage of participants
The Utilization of Sexual Medications/Devices Questionaire Baseline medications/devices question	24.5 percentage of participants	23.0 percentage of participants
The Utilization of Sexual Medications/Devices Questionaire 6 mo. penile prosthesis question	2.5 percentage of participants	0.6 percentage of participants
The Utilization of Sexual Medications/Devices Questionaire 6 mo. medications/devices question	25.0 percentage of participants	24.1 percentage of participants
The Utilization of Sexual Medications/Devices Questionaire 12 mo. penile prosthesis question	0.3 percentage of participants	0.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline, 6 months, 12 months, 24 months, and 5 years

Population: Eligible patients with a follow-up HSCL-25 who did not withdraw consent

Anxiety and depression were measured with the Hopkins Symptom Checklist (HSCL-25). It consists of 25 items: Part I of the HSCL-25 has 10 items for anxiety symptoms; Part II has 15 items for depression symptoms. The scale for each question includes four categories of response ("Not at all," "A little," "Quite a bit," "Extremely," rated 1 to 4, respectively). Two scores are calculated: the total score is the average of all 25 items and ranges from 0 to 100. A higher score indicates worse symptoms. The HSCL-25 tool was assessed at baseline, 6 months, 12 months, 24 months, and 5 years. For each patient, the change in score from baseline to the time point is calculated by subtracting the baseline value from the time point value.

Outcome measures

Measure	Conventional 3D-CRT n=298 Participants Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy	Hypofractionated 3D-CRT n=336 Participants Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
Change From Baseline in Assessment of Anxiety and Depression Using the HSCL-25 24 months	31.1 units on a scale Standard Deviation 7.5	31.7 units on a scale Standard Deviation 7.7
Change From Baseline in Assessment of Anxiety and Depression Using the HSCL-25 5 years	30.8 units on a scale Standard Deviation 7.1	32.1 units on a scale Standard Deviation 7.9
Change From Baseline in Assessment of Anxiety and Depression Using the HSCL-25 6 months	31.2 units on a scale Standard Deviation 7.8	31.8 units on a scale Standard Deviation 8.1
Change From Baseline in Assessment of Anxiety and Depression Using the HSCL-25 12 months	31.2 units on a scale Standard Deviation 7.3	32.2 units on a scale Standard Deviation 9

SECONDARY outcome

Timeframe: Baseline, 6 months, 12 months, 24 months, and 5 years

Population: Eligible patients with a baseline or follow-up EQ-5D score who did not withdraw consent

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 stat and 1 -Best health state. A two-sided Wilcoxon test with alpha 0.05 was used due to the skewed, thus non-normal, nature of the data.

Outcome measures

Measure	Conventional 3D-CRT n=418 Participants Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy	Hypofractionated 3D-CRT n=439 Participants Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
EQ-5D Scores Baseline Index Score	1.0 units on a scale Interval 0.8 to 1.0	1.0 units on a scale Interval 0.8 to 1.0
EQ-5D Scores Baseline VAS Score	85.0 units on a scale Interval 79.0 to 90.0	82.0 units on a scale Interval 75.0 to 90.0
EQ-5D Scores 6 mo. VAS Score	85.0 units on a scale Interval 75.0 to 90.0	85.0 units on a scale Interval 75.0 to 90.0
EQ-5D Scores 6 mo. Index Score	1.0 units on a scale Interval 0.8 to 1.0	1.0 units on a scale Interval 0.8 to 1.0
EQ-5D Scores 12 mo. VAS Score	85.0 units on a scale Interval 75.0 to 90.0	81.5 units on a scale Interval 75.0 to 90.0
EQ-5D Scores 12 mo. Index Score	1.0 units on a scale Interval 0.8 to 1.0	1.0 units on a scale Interval 0.8 to 1.0
EQ-5D Scores 24 mo. VAS Score	85.0 units on a scale Interval 75.0 to 90.0	85.0 units on a scale Interval 75.0 to 90.0
EQ-5D Scores 24 mo. Index Score	1.0 units on a scale Interval 0.8 to 1.0	1.0 units on a scale Interval 0.8 to 1.0
EQ-5D Scores 60 mo. VAS Score	85.0 units on a scale Interval 75.0 to 90.0	82.0 units on a scale Interval 73.0 to 90.0
EQ-5D Scores 60 mo. Index Score	0.9 units on a scale Interval 0.8 to 1.0	0.9 units on a scale Interval 0.8 to 1.0

SECONDARY outcome

Timeframe: From baseline to 5 years from the start of treatment

Population: This analysis was not conducted because there were no differences in EQ-5D scores. See results presented for Outcome Measure 10: Evaluation and Comparison of the Cost-utility of Each Treatment Arm Using EQ-5D.

To examine trade-offs between the survival time and QOL, we were to combine them for each patient into two single measurements: quality adjusted live year (QALY) and quality adjusted disease-free survival year (QADFSY). We were to use Glasziou's multiple health-state (Q-TWiST) models to use the repeated measures of EQ-5D.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline biomarker collection. Analysis would occur after the primary endpoint analysis.

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

OTHER_PRE_SPECIFIED outcome

Timeframe: From baseline to 5 years from the start of treatment.

Outcome measures

Outcome data not reported

Adverse Events

Conventional 3D-CRT

Serious events: 28 serious events

Other events: 466 other events

Deaths: 0 deaths

Hypofractionated 3D-CRT

Serious events: 32 serious events

Other events: 497 other events

Deaths: 0 deaths

Serious adverse events

Measure	Conventional 3D-CRT n=534 participants at risk CConventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy	Hypofractionated 3D-CRT n=545 participants at risk Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
Blood and lymphatic system disorders Blood/bone marrow - Other	0.00% 0/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.18% 1/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Blood and lymphatic system disorders Hemoglobin	0.19% 1/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Arrhythmia NOS	0.19% 1/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Atrial fibrillation	0.75% 4/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Cardio-respiratory arrest	0.19% 1/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Palpitations	0.19% 1/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Sinus bradycardia	0.19% 1/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Constipation	0.37% 2/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Diarrhea NOS	0.37% 2/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Duodenal obstruction	0.19% 1/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Fecal incontinence	0.19% 1/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Gastrointestinal - Other	0.19% 1/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Pancreatitis NOS	0.00% 0/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.18% 1/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Proctalgia	0.00% 0/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.18% 1/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Proctitis NOS	0.56% 3/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.37% 2/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Rectal hemorrhage	0.37% 2/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.37% 2/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Rectal perforation	0.19% 1/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Edema: limb	0.19% 1/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Fatigue	0.19% 1/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Hepatobiliary disorders Cholecystitis NOS	0.00% 0/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.18% 1/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Gallbladder (cholecystitis)	0.00% 0/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.18% 1/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Pneumonia NOS	0.19% 1/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Hypercholesterolemia	0.00% 0/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.18% 1/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Metabolic/laboratory - Other	0.19% 1/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Acidosis NOS	0.00% 0/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.18% 1/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Back pain	0.19% 1/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-lower	0.00% 0/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.18% 1/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Neck pain	0.19% 1/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Cerebral ischemia	0.00% 0/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.37% 2/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Convulsions NOS	0.19% 1/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Dizziness	0.00% 0/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.18% 1/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Depression	0.00% 0/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.18% 1/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Libido decreased	0.19% 1/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Bladder obstruction	0.00% 0/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.18% 1/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Bladder pain	0.00% 0/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.18% 1/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Pollakiuria	0.75% 4/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.92% 5/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Renal/genitourinary - Other	0.00% 0/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.37% 2/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Urethral stricture	0.19% 1/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Urinary bladder hemorrhage	0.00% 0/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.18% 1/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Urinary incontinence	0.00% 0/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.37% 2/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Urinary retention	0.37% 2/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.37% 2/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Reproductive system and breast disorders Ejaculatory disorder NOS	0.19% 1/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Reproductive system and breast disorders Erectile dysfunction NOS	0.75% 4/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.55% 3/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.19% 1/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.18% 1/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Cough	0.19% 1/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.56% 3/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.55% 3/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Vascular disorders Thrombosis	0.19% 1/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.

Other adverse events

Measure	Conventional 3D-CRT n=534 participants at risk CConventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy	Hypofractionated 3D-CRT n=545 participants at risk Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
Renal and urinary disorders Urinary incontinence	12.0% 64/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	16.5% 90/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Urinary retention	23.0% 123/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	26.2% 143/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Reproductive system and breast disorders Ejaculatory disorder NOS	5.6% 30/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	6.2% 34/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Constipation	10.3% 55/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	10.8% 59/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Diarrhea NOS	32.4% 173/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	38.7% 211/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Fecal incontinence	3.2% 17/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	6.4% 35/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Gastrointestinal - Other	9.2% 49/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	13.2% 72/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Hemorrhoids	6.7% 36/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	9.5% 52/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Proctitis NOS	21.9% 117/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	29.7% 162/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Rectal hemorrhage	16.5% 88/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	25.1% 137/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Fatigue	30.1% 161/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	28.4% 155/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Pain - Other	6.0% 32/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	7.5% 41/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Libido decreased	5.2% 28/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	6.4% 35/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Bladder pain	5.8% 31/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	4.6% 25/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Cystitis NOS	16.5% 88/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	19.6% 107/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Pollakiuria	70.8% 378/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	74.1% 404/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Renal/genitourinary - Other	15.7% 84/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	23.1% 126/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Urethral pain	2.8% 15/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	5.9% 32/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Reproductive system and breast disorders Erectile dysfunction NOS	37.3% 199/534 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.	39.3% 214/545 Eligible patients with adverse event data who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.

Additional Information

Wendy Seiferheld, M.S.

NRG Oncology

Email: seiferheldw@nrgoncology.org

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.
• Publication restrictions are in place

Restriction type: OTHER