Trial Outcomes & Findings for Radiation Therapy in Treating Patients With Stage II Prostate Cancer (NCT NCT00033631)
NCT ID: NCT00033631
Last Updated: 2023-01-18
Results Overview
Survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier Method. Patients last know to be alive are censored at date of last contact.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1534 participants
Primary outcome timeframe
From randomization to date of failure (death) or last follow-up. Analysis occurs after all patients have been potentially followed for 8 years.
Results posted on
2023-01-18
Participant Flow
Participant milestones
| Measure |
70.2 Gy
70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
|
79.2 Gy
79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
|
|---|---|---|
|
Overall Study
STARTED
|
769
|
763
|
|
Overall Study
COMPLETED
|
751
|
748
|
|
Overall Study
NOT COMPLETED
|
18
|
15
|
Reasons for withdrawal
| Measure |
70.2 Gy
70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
|
79.2 Gy
79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
14
|
11
|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
Baseline Characteristics
Radiation Therapy in Treating Patients With Stage II Prostate Cancer
Baseline characteristics by cohort
| Measure |
70.2 Gy
n=751 Participants
70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
|
79.2 Gy
n=748 Participants
79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
|
Total
n=1499 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71 years
n=5 Participants
|
71 years
n=7 Participants
|
71 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
|
751 Participants
n=5 Participants
|
748 Participants
n=7 Participants
|
1499 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to date of failure (death) or last follow-up. Analysis occurs after all patients have been potentially followed for 8 years.Population: All eligible patients who did not withdraw consent
Survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier Method. Patients last know to be alive are censored at date of last contact.
Outcome measures
| Measure |
70.2 Gy
n=751 Participants
70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
|
79.2 Gy
n=748 Participants
79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
|
|---|---|---|
|
Overall Survival
|
88.5 percentage of participants
Interval 86.2 to 90.9
|
88.1 percentage of participants
Interval 85.7 to 90.4
|
SECONDARY outcome
Timeframe: From randomization to date of failure (3 consecutive rises) or death or last follow-up. Analysis occurred after patients have been potentially followed for 5 years.Population: All eligible patients who did not withdraw consent
Failure is defined as having 3 consecutive elevations of post-treatment PSA or starting hormones after one or more elevations in post-treatment PSA but before three consecutive elevations were documented. The failure day date was the midpoint between last non-rising PSA and first PSA rise. Failure rates are estimated by the cumulative incidence method. Patients last known to be alive are censored at date of last contact.
Outcome measures
| Measure |
70.2 Gy
n=751 Participants
70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
|
79.2 Gy
n=748 Participants
79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
|
|---|---|---|
|
Prostate-specific Antigen (PSA) Failure by American Society for Therapeutic Radiology and Oncology (ASTRO) Definition
|
40.2 percentage of participants
Interval 36.6 to 43.7
|
25.2 percentage of participants
Interval 22.1 to 28.4
|
SECONDARY outcome
Timeframe: From randomization to date of failure (death due to prostate cancer) or death from other cause or last follow-up. Analysis occurs at the same time as the primary endpoint.Population: All eligible patients who did not withdraw consent
Survival time is defined as time from randomization to the date of death due to prostate cancer and is estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact. Death due to prostate cancer was defined as primary cause of death certified as due to prostate cancer, or death in association with any of the following conditions: Further clinical tumor progression occurring after initiation of salvage anti-tumor therapy, a rise (that exceeds 1.0 ng/ml) in the serum PSA level on at least two consecutive occasions that occurred during or after salvage androgen suppression therapy, or disease progression in the absence of any anti-tumor therapy.
Outcome measures
| Measure |
70.2 Gy
n=751 Participants
70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
|
79.2 Gy
n=748 Participants
79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
|
|---|---|---|
|
Disease Specific Survival
|
1.4 percentage of participants
Interval 0.7 to 2.5
|
0.8 percentage of participants
Interval 0.4 to 1.8
|
SECONDARY outcome
Timeframe: From randomization to date of failure (local progression) or death or last follow-up. Analysis occurs at the same time as the primary endpoint.Population: All eligible patients who have not withdrawn consent
Failure time is defined as time from randomization to the date of progression (increase in palpable abnormality), failure of regression of the palpable tumor by two years, and redevelopment of a palpable abnormality after complete disappearance of previous abnormalities. Failure rates are estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact.
Outcome measures
| Measure |
70.2 Gy
n=751 Participants
70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
|
79.2 Gy
n=748 Participants
79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
|
|---|---|---|
|
Local Progression
|
3.5 percentage of participants
Interval 2.3 to 5.0
|
1.8 percentage of participants
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: From randomization to date of failure (distant metastasis) or death or last follow-up. Analysis occurs at the same time as the primary endpoint.Population: All eligible patients who have not withdrawn consent
Failure time is defined as time from randomization to the date of documented regional nodal recurrence or development of distant disease. Failure rates are estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact.
Outcome measures
| Measure |
70.2 Gy
n=751 Participants
70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
|
79.2 Gy
n=748 Participants
79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
|
|---|---|---|
|
Distant Metastases
|
3.1 percentage of participants
Interval 2.0 to 4.6
|
2.2 percentage of participants
Interval 1.3 to 3.5
|
SECONDARY outcome
Timeframe: From the start of treatment to 90 days. Analysis occurs at the same time as the primary endpointPopulation: Eligible patients with acute adverse event data who did not withdraw consent.
Rate of acute 2+ grade genitourinary(GU)/gastrointestinal(GI) toxicity graded by Common Toxicity Criteria (CTC) version 2.0
Outcome measures
| Measure |
70.2 Gy
n=733 Participants
70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
|
79.2 Gy
n=728 Participants
79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
|
|---|---|---|
|
Grade 2 or Greater Genitourinary or Gastrointestinal Toxicity
|
18.8 percentage of participants
|
21.0 percentage of participants
|
SECONDARY outcome
Timeframe: Twelve months from randomizationPopulation: Eligible patients with a response of 4 or 5 (most times/almost always/always) to IIEF question 1 at baseline
The International Index of Erectile Function Questionnaire (IIEF) is the primary measure for erectile function (ED). IIEF question number 1 ("How often were you able to get an erection during sexual activity?") is scored from: none/almost never (response 0-1) or \< half the time (response 2-3) to most times/almost always/always (response 4-5). A response of 0 to 3 on question number 1 of the IIEF is considered erectile dysfunction.
Outcome measures
| Measure |
70.2 Gy
n=134 Participants
70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
|
79.2 Gy
n=145 Participants
79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
|
|---|---|---|
|
Percentage of Participants With Erectile Disfuction at 12 Months
|
38.06 percentage of participants
Interval 29.84 to 46.28
|
49.66 percentage of participants
Interval 41.52 to 57.79
|
SECONDARY outcome
Timeframe: Baseline and 12 months from randomizationPopulation: Eligible participants with baseline and 12 month SQLI
The SQLI measures quality of life for patients with cancer and other chronic diseases. Possible scores range from 0 to 10, with higher scores indicating a better outcome. Change from Baseline is defined as 12 month SQLI - baseline SQLI and is classified as follows: Improvement: when change \>= to the standard error of measurement with reliability quotient of 0.5 (SEM); Stable: when -SEM \< change \< SEM; Declined: when change \<= SEM.
Outcome measures
| Measure |
70.2 Gy
n=547 Participants
70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
|
79.2 Gy
n=517 Participants
79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
|
|---|---|---|
|
Number of Participants With Improved, Stable, and Declined Spitzer Quality of Life Index (SQLI) at 12 Months
Improved
|
91 Participants
|
91 Participants
|
|
Number of Participants With Improved, Stable, and Declined Spitzer Quality of Life Index (SQLI) at 12 Months
Stable
|
366 Participants
|
331 Participants
|
|
Number of Participants With Improved, Stable, and Declined Spitzer Quality of Life Index (SQLI) at 12 Months
Declined
|
90 Participants
|
95 Participants
|
SECONDARY outcome
Timeframe: From randomization to 5 years.Population: This analysis will not be done because we are unable to find the required algorithm for converting SQLI scores into utilities, which is needed for quality adjusted survival analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization to date of failure (tumor progression) or last follow-up. Analysis can occur any time after the primary endpoint analysis.Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization to last follow-up. Analysis can occur any time after the primary endpoint analysis.Outcome measures
Outcome data not reported
Adverse Events
70.2 Gy
Serious events: 30 serious events
Other events: 714 other events
Deaths: 0 deaths
79.2 Gy
Serious events: 43 serious events
Other events: 704 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
70.2 Gy
n=744 participants at risk
70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 Fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
|
79.2 Gy
n=737 participants at risk
79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 44 Fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
|
|---|---|---|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/744
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.14%
1/737
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.27%
2/744
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.14%
1/737
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Abdominal pain NOS
|
0.13%
1/744
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/737
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Diarrhea (with colostomy)
|
0.00%
0/744
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.14%
1/737
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Diarrhea NOS
|
0.27%
2/744
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/737
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Late RT Toxicity: Bowel : NOS
|
0.13%
1/744
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.14%
1/737
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Late RT Toxicity: Other GI : NOS
|
0.13%
1/744
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.54%
4/737
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Chest pain
|
0.13%
1/744
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/737
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Injection site reaction NOS
|
0.00%
0/744
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.14%
1/737
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Late RT Toxicity: Other : NOS
|
0.13%
1/744
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.41%
3/737
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Pain due to radiation
|
0.00%
0/744
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.27%
2/737
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Pain-other
|
0.13%
1/744
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/737
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/744
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.27%
2/737
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Late RT Toxicity: Bladder/Other GU: NOS
|
0.00%
0/744
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.41%
3/737
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urinary incontinence
|
2.8%
21/744
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.8%
21/737
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urinary retention
|
0.13%
1/744
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.27%
2/737
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea NOS
|
0.00%
0/744
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.14%
1/737
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Skin-Other
|
0.00%
0/744
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.27%
2/737
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Hemorrhage-Other
|
0.00%
0/744
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.27%
2/737
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
Other adverse events
| Measure |
70.2 Gy
n=744 participants at risk
70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 Fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
|
79.2 Gy
n=737 participants at risk
79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 44 Fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea NOS
|
7.8%
58/744
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
6.8%
50/737
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Late RT Toxicity: Bowel : NOS
|
12.1%
90/744
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
17.4%
128/737
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Late RT Toxicity: Other GI : NOS
|
12.1%
90/744
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.5%
107/737
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Proctitis NOS
|
4.4%
33/744
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
6.1%
45/737
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Fatigue
|
6.9%
51/744
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
6.9%
51/737
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Late RT Toxicity: Other : NOS
|
9.1%
68/744
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.2%
90/737
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Dysuria
|
7.0%
52/744
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.2%
53/737
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Late RT Toxicity: Bladder/Other GU: NOS
|
13.3%
99/744
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
17.1%
126/737
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urinary frequency
|
76.1%
566/744
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
79.4%
585/737
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urinary incontinence
|
31.5%
234/744
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
31.1%
229/737
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Reproductive system and breast disorders
Impotence
|
82.1%
611/744
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
81.3%
599/737
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
Additional Information
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