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Radiation Therapy With or Without Bicalutamide for Recurrent pT3N0 Prostate Cancer After Radical Prostatectomy

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ClinicalTrials.gov Identifier: NCT00002874
Recruitment Status : Active, not recruiting
First Posted : January 27, 2003
Results First Posted : August 18, 2017
Last Update Posted : August 18, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Southwest Oncology Group
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Drug: bicalutamide
Radiation: radiation therapy
Drug: placebo
Enrollment 840
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bicalutamide Placebo
Hide Arm/Group Description Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years) Radiation therapy (64.8 Gy) + placebo (daily 2 years)
Period Title: Overall Study
Started 421 419
Completed [1] 376 384
Not Completed 45 35
Reason Not Completed
Withdrawal by Subject             1             1
Protocol Violation             44             34
[1]
Subjects with data available for the primary analysis are considered to have completed the study.
Arm/Group Title Bicalutamide Placebo Total
Hide Arm/Group Description Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years) Radiation therapy (64.8 Gy) + placebo (daily 2 years) Total of all reporting groups
Overall Number of Baseline Participants 376 384 760
Hide Baseline Analysis Population Description
Eligible patients who have not withdrawn
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 376 participants 384 participants 760 participants
65
(45 to 81)
65
(40 to 83)
65
(40 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 376 participants 384 participants 760 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
376
 100.0%
384
 100.0%
760
 100.0%
1.Primary Outcome
Title Overall Survival (12-year Rates Reported)
Hide Description

Overall survival rates were estimated by the Kaplan-Meier method, with failure defined as death by any cause. Four-year follow-up was required of all patients, twelve-year rates are reported. Four-year follow-up was required of all patients, but twelve-year rates were reported.

Patients are followed until death.

Time Frame From date of randomization to 12 years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who did not withdraw consent.
Arm/Group Title Placebo Bicalutamide
Hide Arm/Group Description:
Radiation therapy (64.8 Gy) + placebo (daily 2 years)
Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
Overall Number of Participants Analyzed 394 376
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
71.3
(66.5 to 76.0)
76.3
(71.9 to 80.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bicalutamide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.020
Comments One-sided significance level = 0.046 to preserve overall significance level of 0.05 for the study.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.59 to 0.98
Estimation Comments Stratifying variables were fixed covariates: prior hormone therapy (yes/no), entry prostate-specific antigen (PSA) (1.6-4.0 vs. 0.2-1.5), PSA nadir after surgery (< 0.5 vs. >= 0.5), positive surgical margins (yes/no). Reference level = placebo arm.
2.Secondary Outcome
Title Non-Prostate Cancer Death (12-year Rates Reported)
Hide Description

Non-prostate cancer death rates were estimated by the cumulative incidence method, with failure defined as any death that does not fall into the following categories: death due to prostate cancer or complications of protocol treatment (centrally reviewed), death with known progressive metastatic disease while on salvage hormone therapy, or death with a known rising PSA while on salvage hormone therapy. All other deaths are considered competing risks. Patients alive at time of analysis were censored. Any other death was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported.

Patients are followed until death. "Non-Prostate cancer death" is a more accurate wording for the protocol endpoint of "non-disease-specific survival", and matches the protocol definition.

Time Frame From date of randomization to 12 years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who did not withdraw consent.
Arm/Group Title Placebo Bicalutamide
Hide Arm/Group Description:
Radiation therapy (64.8 Gy) + placebo (daily 2 years)
Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
Overall Number of Participants Analyzed 376 384
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
15.3
(11.8 to 19.3)
17.9
(14.0 to 22.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bicalutamide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.289
Comments [Not Specified]
Method Gray’s test
Comments One-sided test
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.10
Confidence Interval (2-Sided) 95%
0.79 to 1.53
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Second PSA Recurrence (12-year Rates Reported)
Hide Description Second PSA recurrence (SPSAR) rates (i.e. first PSA failure on study) were estimated by the cumulative incidence method, with failure defined as the first occurrence of one of the following events: 1. Increase in PSA following protocol treatment according to the following criteria met during protocol treatment: If PSA dropped to undetectable level (<0.2 ng/ml) during protocol treatment (PT) then failure = increase after PT to >= 0.5 ng/ml ; If PSA decreased to a detectable level (≥ 0.2 ng/ml) during PT, then failure = increase PT of >= 0.3 ng/ml above the lowest detectable level; If PSA did not decrease during PT then failure = increase in PSA after PT of >= 0.5 ng/ml above entry PSA level. 2. The start of salvage hormone therapy. Patients alive without SPSAR at time of analysis were censored. Death without SPSAR was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death.
Time Frame From date of randomization to 12 years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who did not withdraw consent.
Arm/Group Title Placebo Bicalutamide
Hide Arm/Group Description:
Radiation therapy (64.8 Gy) + placebo (daily 2 years)
Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
Overall Number of Participants Analyzed 376 384
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
67.9
(62.7 to 72.5)
44.0
(38.8 to 49.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bicalutamide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Gray’s test
Comments One-sided test
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.48
Confidence Interval (2-Sided) 95%
0.40 to 0.58
Estimation Comments Reference level = placebo arm
4.Secondary Outcome
Title Third PSA Recurrence (12-year Rates Reported)
Hide Description Third PSA recurrence rates (i.e. second PSA failure on study) were estimated by the cumulative incidence method, with failure defined as PSA value of 0.5ng/ml or higher or any disease progression after starting salvage hormone therapy. Patients alive without third PSA recurrence at time of analysis were censored. Death without third PSA recurrence was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death.
Time Frame From start of salvage hormone therapy to 12 years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who did not withdraw consent and who started salvage hormone therapy.
Arm/Group Title Placebo Bicalutamide
Hide Arm/Group Description:
Radiation therapy (64.8 Gy) + placebo (daily 2 years)
Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
Overall Number of Participants Analyzed 167 111
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
80.7
(73.2 to 86.3)
84.2
(75.0 to 90.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bicalutamide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.213
Comments [Not Specified]
Method Gray’s test
Comments One-sided test
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
0.85 to 1.46
Estimation Comments Reference level = placebo arm
5.Secondary Outcome
Title PSA Complete Response at End of Protocol Treatment
Hide Description Complete response is defined as a drop in PSA on protocol treatment to less than 0.2 ng/ml. Note that when the study opened many institutions could not detect PSA < 05 ng/ml.
Time Frame End of protocol treatment, which is planned to last for two years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who did not withdraw consent.
Arm/Group Title Placebo Bicalutamide
Hide Arm/Group Description:
Radiation therapy (64.8 Gy) + placebo (daily 2 years)
Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
Overall Number of Participants Analyzed 376 384
Measure Type: Count of Participants
Unit of Measure: Participants
259
  68.9%
360
  93.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bicalutamide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
6.Secondary Outcome
Title Distant Failure (12-year Rates Reported)
Hide Description Distant failure rates were estimated by the cumulative incidence method, with failure defined as the first occurrence of distant failure. Patients alive without distant metastases at time of analysis were censored. Death without distant metastasis was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death.
Time Frame From date of randomization to 12 years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who did not withdraw consent.
Arm/Group Title Placebo Bicalutamide
Hide Arm/Group Description:
Radiation therapy (64.8 Gy) + placebo (daily 2 years)
Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
Overall Number of Participants Analyzed 376 384
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
23.0
(18.8 to 27.5)
14.5
(11.1 to 18.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bicalutamide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Gray’s test
Comments One-sided test
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.63
Confidence Interval (2-Sided) 95%
0.46 to 0.87
Estimation Comments Reference level = placebo arm
7.Secondary Outcome
Title Prostate Cancer Death (12-year Rates Reported)
Hide Description Prostate cancer death rates were estimated by the cumulative incidence method, with failure defined as death due to prostate cancer or complications of protocol treatment (centrally reviewed), death with known progressive metastatic disease while on salvage hormone therapy, or death with a known rising PSA while on salvage hormone therapy. Patients alive at time of analysis were censored. Any other death was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death. "Prostate cancer death" is a more accurate wording for the protocol endpoint of "disease-specific survival", and matches the protocol definition.
Time Frame From date of randomization to 12 years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who did not withdraw consent.
Arm/Group Title Placebo Bicalutamide
Hide Arm/Group Description:
Radiation therapy (64.8 Gy) + placebo (daily 2 years)
Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
Overall Number of Participants Analyzed 376 384
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
13.4
(10.1 to 17.2)
5.8
(3.6 to 8.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bicalutamide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Gray’s test
Comments One-sided test
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.49
Confidence Interval (2-Sided) 95%
0.32 to 0.74
Estimation Comments Reference level = placebo arm
8.Secondary Outcome
Title Progression-free Survival (12-year Rates Reported)
Hide Description Progress-free survival rates were estimated by the Kaplan-Meier method, with failure defined as the first occurrence of PSA failure, local, regional or distant failure, or death from any cause. Patients alive without progression at time of analysis were censored. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death. "Progression-free Survival" is more accurate wording for the protocol endpoint of "Freedom from Progression", and matches the protocol definition.
Time Frame From date of randomization to 12 years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who did not withdraw consent.
Arm/Group Title Placebo Bicalutamide
Hide Arm/Group Description:
Radiation therapy (64.8 Gy) + placebo (daily 2 years)
Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
Overall Number of Participants Analyzed 376 384
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
23.9
(19.4 to 28.4)
38.8
(33.7 to 43.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bicalutamide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Log Rank
Comments One-side test
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.60
Confidence Interval (2-Sided) 95%
0.50 to 0.71
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Grade 3+ Toxicity
Hide Description Adverse events are graded using the Cooperative Group Common Toxicity Criteria and the Radiation Therapy Oncology Group (RTOG) Radiation Morbidity Scoring. Grade refers to severity, assigning Grades 1 through 5 based on this general guideline: Grade 0 None, Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related toxicity. Toxicities reported to have occurred within 90 days from the start of radiotherapy are reported as "Acute Radiotherapy", all later toxicities are reported as "Hormone therapy and late radiotherapy toxicity". The highest grade toxicity event per subject is counted within each of these time periods. Four-year follow-up was required of all patients; patients are followed until death.
Time Frame From date of randomization to four years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started protocol treatment and did not withdraw consent.
Arm/Group Title Placebo Bicalutamide
Hide Arm/Group Description:
Radiation therapy (64.8 Gy) + placebo (daily 2 years)
Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
Overall Number of Participants Analyzed 374 382
Measure Type: Number
Unit of Measure: participants
Acute radiotherapy toxicity 17 8
Hormone therapy and late radiotherapy toxicity 73 100
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bicalutamide
Comments Acute radiotherapy toxicity
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.060
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Bicalutamide
Comments Hormone therapy and late radiotherapy toxicity
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.029
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Subjects who started protocol treatment are included. Subjects experiencing more than one of a given toxicity are counted only once for that toxicity. Adverse events were graded with a combination of the Cooperative Group Common Toxicity Criteria and RTOG Acute and Late Radiation Morbidity Scoring. Grade refers to severity of toxicity assigning Grades 1-5: Grade 0 None, Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related toxicity.
 
Arm/Group Title Placebo Bicalutamide
Hide Arm/Group Description Radiation therapy (64.8 Gy) + placebo (daily 2 years) Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
All-Cause Mortality
Placebo Bicalutamide
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Bicalutamide
Affected / at Risk (%) Affected / at Risk (%)
Total   82/382 (21.47%)   105/374 (28.07%) 
Blood and lymphatic system disorders     
Acute RT Toxicity: Hematologic: NOS  1  3/382 (0.79%)  2/374 (0.53%) 
Hematologic: NOS * 2  6/382 (1.57%)  4/374 (1.07%) 
Cardiac disorders     
Cardiac: NOS * 2  17/382 (4.45%)  6/374 (1.60%) 
Gastrointestinal disorders     
Acute RT Toxicity: Bowel: NOS  1  1/382 (0.26%)  3/374 (0.80%) 
Bowel/GI: NOS * 2  10/382 (2.62%)  6/374 (1.60%) 
Nausea/vomiting: NOS * 2  1/382 (0.26%)  1/374 (0.27%) 
General disorders     
Acute RT Toxicity: Other: NOS  1  0/382 (0.00%)  1/374 (0.27%) 
Other: NOS * 3  15/382 (3.93%)  13/374 (3.48%) 
Pain: NOS * 2  2/382 (0.52%)  6/374 (1.60%) 
Hepatobiliary disorders     
Liver: NOS * 2  3/382 (0.79%)  1/374 (0.27%) 
Nervous system disorders     
Neurologic: NOS * 2  8/382 (2.09%)  4/374 (1.07%) 
Renal and urinary disorders     
Acute RT Toxicity: Bladder: NOS  1  4/382 (1.05%)  11/374 (2.94%) 
Bladder/GU: NOS * 2  28/382 (7.33%)  29/374 (7.75%) 
Reproductive system and breast disorders     
Gynecomastia: NOS * 3  14/382 (3.66%)  0/374 (0.00%) 
Impotence: NOS * 3  28/382 (7.33%)  16/374 (4.28%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea: NOS * 2  3/382 (0.79%)  1/374 (0.27%) 
Skin and subcutaneous tissue disorders     
Skin-general: NOS * 2  1/382 (0.26%)  2/374 (0.53%) 
Vascular disorders     
Hot flashes: NOS * 3  3/382 (0.79%)  0/374 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, RTOG Acute RT Morb.
2
Term from vocabulary, Coop. Group CTC
3
Term from vocabulary, General criteria
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Bicalutamide
Affected / at Risk (%) Affected / at Risk (%)
Total   346/382 (90.58%)   374/374 (100.00%) 
Blood and lymphatic system disorders     
Acute RT Toxicity: Hematologic: NOS  1  34/382 (8.90%)  28/374 (7.49%) 
Hematologic: NOS * 2  58/382 (15.18%)  35/374 (9.36%) 
Cardiac disorders     
Cardiac: NOS * 2  19/382 (4.97%)  9/374 (2.41%) 
Gastrointestinal disorders     
Acute RT Toxicity: Bowel: NOS  1  232/382 (60.73%)  235/374 (62.83%) 
Bowel/GI: NOS * 2  192/382 (50.26%)  170/374 (45.45%) 
Nausea/vomiting: NOS * 2  19/382 (4.97%)  12/374 (3.21%) 
General disorders     
Acute RT Toxicity: Other: NOS  1  68/382 (17.80%)  50/374 (13.37%) 
Other: NOS * 3  127/382 (33.25%)  97/374 (25.94%) 
Pain: NOS * 2  53/382 (13.87%)  63/374 (16.84%) 
Injury, poisoning and procedural complications     
Acute RT Toxicity: Skin: NOS  1  87/382 (22.77%)  88/374 (23.53%) 
Skin-within XRT field: NOS * 2  46/382 (12.04%)  34/374 (9.09%) 
Nervous system disorders     
Neurologic: NOS * 2  21/382 (5.50%)  26/374 (6.95%) 
Renal and urinary disorders     
Acute RT Toxicity: Bladder: NOS  1  188/382 (49.21%)  165/374 (44.12%) 
Bladder/GU: NOS * 2  230/382 (60.21%)  220/374 (58.82%) 
Reproductive system and breast disorders     
Gynecomastia: NOS * 3  262/382 (68.59%)  41/374 (10.96%) 
Impotence: NOS * 3  45/382 (11.78%)  35/374 (9.36%) 
Skin and subcutaneous tissue disorders     
Skin-general: NOS * 2  49/382 (12.83%)  15/374 (4.01%) 
Vascular disorders     
Hot flashes: NOS * 3  81/382 (21.20%)  66/374 (17.65%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, RTOG Acute RT Morb.
2
Term from vocabulary, Coop. Group CTC
3
Term from vocabulary, General criteria
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
Results Point of Contact
Name/Title: Wendy Seiferheld, M.S.
Organization: NRG Oncology
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00002874     History of Changes
Other Study ID Numbers: RTOG-9601
CDR0000065158
RTOG-R9601
First Submitted: November 1, 1999
First Posted: January 27, 2003
Results First Submitted: June 6, 2017
Results First Posted: August 18, 2017
Last Update Posted: August 18, 2017