Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Radiation Therapy in Treating Patients With Stage II Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00033631
Recruitment Status : Active, not recruiting
First Posted : January 27, 2003
Results First Posted : February 8, 2017
Last Update Posted : May 22, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Radiation: 70.2 Gy 3D-CRT/IMRT
Radiation: 79.2 Gy 3D-CRT/IMRT
Enrollment 1532
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 70.2 Gy 79.2 Gy
Hide Arm/Group Description 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 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.
Period Title: Overall Study
Started 769 763
Completed 751 [1] 748 [1]
Not Completed 18 15
Reason Not Completed
Protocol Violation             14             11
Withdrawal by Subject             4             4
[1]
Subjects with data available for the primary analysis are considered to have completed the study.
Arm/Group Title 70.2 Gy 79.2 Gy Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 751 748 1499
Hide Baseline Analysis Population Description
All eligible patients who did not withdraw consent
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 751 participants 748 participants 1499 participants
71
(33 to 86)
71
(49 to 87)
71
(33 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 751 participants 748 participants 1499 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
751
 100.0%
748
 100.0%
1499
 100.0%
1.Primary Outcome
Title Overall Survival
Hide Description 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.
Time Frame From randomization to date of failure (death) or last follow-up. Analysis occurs after all patients have been potentially followed for 8 years.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who did not withdraw consent
Arm/Group Title 70.2 Gy 79.2 Gy
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 751 748
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
88.5
(86.2 to 90.9)
88.1
(85.7 to 90.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 70.2 Gy, 79.2 Gy
Comments The original target sample size was 1520 patients with a requirement of 715 deaths to test the hypothesis of overall survival (OS) efficacy of the 79.2 Gy arm. The trial was designed to detect a hazard ratio (HR) of 1.30 (standard/high-dose) with 90% statistical power at a one-sided significance level of 0.025.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.98
Comments Two-sided test, significance level = 0.05
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.83 to 1.2
Estimation Comments Reference level = 70.2 Gy arm
2.Secondary Outcome
Title Prostate-specific Antigen (PSA) Failure by American Society for Therapeutic Radiology and Oncology (ASTRO) Definition
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who did not withdraw consent
Arm/Group Title 70.2 Gy 79.2 Gy
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 751 748
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
40.2
(36.6 to 43.7)
25.2
(22.1 to 28.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 70.2 Gy, 79.2 Gy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Two-sided significance level = 0.05
Method Gray's test
Comments Reference arm is 70.2 Gy arm
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.59
Confidence Interval (2-Sided) 95%
0.50 to 0.70
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Disease Specific Survival
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who did not withdraw consent
Arm/Group Title 70.2 Gy 79.2 Gy
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 751 748
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
1.4
(0.7 to 2.5)
0.8
(0.4 to 1.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 70.2 Gy, 79.2 Gy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments [Not Specified]
Method Gray's test
Comments Two-sided significance level = 0.05
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.66
Confidence Interval (2-Sided) 95%
0.38 to 1.15
Estimation Comments Reference level is 70.2 Gy arm
4.Secondary Outcome
Title Local Progression
Hide Description 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.
Time Frame From randomization to date of failure (local progression) or death or last follow-up. Analysis occurs at the same time as the primary endpoint.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who have not withdrawn consent
Arm/Group Title 70.2 Gy 79.2 Gy
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 751 748
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
3.5
(2.3 to 5)
1.8
(1 to 3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 70.2 Gy, 79.2 Gy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Gray's test
Comments Two-sided significance level = 0.05
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.41
Confidence Interval (2-Sided) 95%
0.25 to 0.66
Estimation Comments Reference level = 70.2 Gy arm
5.Secondary Outcome
Title Distant Metastases
Hide Description 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.
Time Frame From randomization to date of failure (distant metastasis) or death or last follow-up. Analysis occurs at the same time as the primary endpoint.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who have not withdrawn consent
Arm/Group Title 70.2 Gy 79.2 Gy
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 751 748
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
3.1
(2.0 to 4.6)
2.2
(1.3 to 3.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 70.2 Gy, 79.2 Gy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.051
Comments Two-sided significance level = 0.05
Method Gray's test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.65
Confidence Interval (2-Sided) 95%
0.42 to 1.01
Estimation Comments Reference level is the 70.2 Gy level
6.Secondary Outcome
Title Grade 2 or Greater Genitourinary or Gastrointestinal Toxicity
Hide Description Rate of acute 2+ grade genitourinary(GU)/gastrointestinal(GI) toxicity graded by Common Toxicity Criteria (CTC) version 2.0
Time Frame From the start of treatment to 90 days. Analysis occurs at the same time as the primary endpoint
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with acute adverse event data who did not withdraw consent.
Arm/Group Title 70.2 Gy 79.2 Gy
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 733 728
Measure Type: Number
Unit of Measure: percentage of participants
18.8 21.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 70.2 Gy, 79.2 Gy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments Two-sided significance level = 0.05
Method Chi-squared
Comments [Not Specified]
7.Secondary Outcome
Title Erectile Function by International Index of Erectile Function (IIEF)
Hide Description [Not Specified]
Time Frame From randomization to 5 years.
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Global Quality of Life (QOL) by Spitzer QOL Index (SQLI)
Hide Description [Not Specified]
Time Frame From randomization to 5 years.
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Quality Adjusted Survival by SQLI
Hide Description This analysis will not be done because there was no difference in survival between the two treatment arms.
Time Frame From randomization to 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 70.2 Gy 79.2 Gy
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Tumor Control Probability
Hide Description [Not Specified]
Time Frame From randomization to date of failure (tumor progression) or last follow-up. Analysis can occur any time after the primary endpoint analysis.
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Normal Tissue Complication Probability
Hide Description [Not Specified]
Time Frame From randomization to last follow-up. Analysis can occur any time after the primary endpoint analysis.
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description 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.
 
Arm/Group Title 70.2 Gy 79.2 Gy
Hide Arm/Group Description 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 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.
All-Cause Mortality
70.2 Gy 79.2 Gy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
70.2 Gy 79.2 Gy
Affected / at Risk (%) Affected / at Risk (%)
Total   30/744 (4.03%)   43/737 (5.83%) 
Cardiac disorders     
Left ventricular failure * 1  0/744 (0.00%)  1/737 (0.14%) 
Myocardial ischaemia * 1  2/744 (0.27%)  1/737 (0.14%) 
Gastrointestinal disorders     
Abdominal pain NOS * 1  1/744 (0.13%)  0/737 (0.00%) 
Diarrhea (with colostomy) * 1  0/744 (0.00%)  1/737 (0.14%) 
Diarrhea NOS * 1  2/744 (0.27%)  0/737 (0.00%) 
Late RT Toxicity: Bowel : NOS  1  1/744 (0.13%)  1/737 (0.14%) 
Late RT Toxicity: Other GI : NOS  1  1/744 (0.13%)  4/737 (0.54%) 
General disorders     
Chest pain * 1  1/744 (0.13%)  0/737 (0.00%) 
Injection site reaction NOS * 1  0/744 (0.00%)  1/737 (0.14%) 
Late RT Toxicity: Other : NOS  1  1/744 (0.13%)  3/737 (0.41%) 
Pain due to radiation * 1  0/744 (0.00%)  2/737 (0.27%) 
Pain-other * 1  1/744 (0.13%)  0/737 (0.00%) 
Renal and urinary disorders     
Dysuria * 1  0/744 (0.00%)  2/737 (0.27%) 
Late RT Toxicity: Bladder/Other GU: NOS  1  0/744 (0.00%)  3/737 (0.41%) 
Urinary incontinence  1  21/744 (2.82%)  21/737 (2.85%) 
Urinary retention * 1  1/744 (0.13%)  2/737 (0.27%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea NOS * 1  0/744 (0.00%)  1/737 (0.14%) 
Skin and subcutaneous tissue disorders     
Skin-Other * 1  0/744 (0.00%)  2/737 (0.27%) 
Vascular disorders     
Hemorrhage-Other * 1  0/744 (0.00%)  2/737 (0.27%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTC (2.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
70.2 Gy 79.2 Gy
Affected / at Risk (%) Affected / at Risk (%)
Total   714/744 (95.97%)   704/737 (95.52%) 
Gastrointestinal disorders     
Diarrhea NOS * 1  58/744 (7.80%)  50/737 (6.78%) 
Late RT Toxicity: Bowel : NOS  1  90/744 (12.10%)  128/737 (17.37%) 
Late RT Toxicity: Other GI : NOS  1  90/744 (12.10%)  107/737 (14.52%) 
Proctitis NOS * 1  33/744 (4.44%)  45/737 (6.11%) 
General disorders     
Fatigue * 1  51/744 (6.85%)  51/737 (6.92%) 
Late RT Toxicity: Other : NOS  1  68/744 (9.14%)  90/737 (12.21%) 
Renal and urinary disorders     
Dysuria * 1  52/744 (6.99%)  53/737 (7.19%) 
Late RT Toxicity: Bladder/Other GU: NOS  1  99/744 (13.31%)  126/737 (17.10%) 
Urinary frequency  1  566/744 (76.08%)  585/737 (79.38%) 
Urinary incontinence  1  234/744 (31.45%)  229/737 (31.07%) 
Reproductive system and breast disorders     
Impotence  1  611/744 (82.12%)  599/737 (81.28%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTC (2.0)
The data monitoring committee (DMC) recommended early reporting of the trial when the third interim analysis futility boundary was crossed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Wendy Seiferheld, M.S.
Organization: NRG Oncology
EMail: seiferheldw@nrgoncology.org
Layout table for additonal information
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00033631     History of Changes
Other Study ID Numbers: RTOG-0126
CDR0000069306
First Submitted: April 9, 2002
First Posted: January 27, 2003
Results First Submitted: December 16, 2016
Results First Posted: February 8, 2017
Last Update Posted: May 22, 2019