This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Radiation Therapy in Treating Patients With Stage II Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00331773
First received: May 30, 2006
Last updated: February 28, 2017
Last verified: February 2017
Results First Received: November 29, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Radiation: Conventional 3D-CRT or IMRT
Radiation: Hypofractionated 3D-CRT or IMRT

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Conventional 3D-CRT   Hypofractionated 3D-CRT
STARTED   558   557 
COMPLETED   542 [1]   550 [1] 
NOT COMPLETED   16   7 
Withdrawal by Subject                6                4 
Protocol Violation                10                3 
[1] Subjects with data available for the primary analysis are considered to have completed the study.



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Eligible patients who did not withdraw consent.

Reporting Groups
  Description
Conventional 3D-CRT 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 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 Total of all reporting groups

Baseline Measures
   Conventional 3D-CRT   Hypofractionated 3D-CRT   Total 
Overall Participants Analyzed 
[Units: Participants]
 542   550   1092 
Age 
[Units: Years]
Median (Full Range)
 67 
 (42 to 85) 
 67 
 (45 to 84) 
 67 
 (42 to 85) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      542 100.0%      550 100.0%      1092 100.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Five-year Disease-free Survival (DFS) Rate   [ Time Frame: Analysis occurs after all patients have been followed for five years. ]

2.  Secondary:   Five-year Local Progression Rate   [ Time Frame: Analysis occurs after all patients have been followed for five years. ]

3.  Secondary:   Five-year Disease-specific Survival Rate   [ Time Frame: Analysis occurs after all patients have been followed for five years. ]

4.  Secondary:   Five-year PSA Failure Rate   [ Time Frame: Analysis occurs after all patients have been followed for five years. ]

5.  Secondary:   Five-year Overall Survival Rate   [ Time Frame: Analysis occurs after all patients have been followed for five years. ]

6.  Secondary:   Frequency of Patients With GU and GI Acute and Late Toxicity   [ Time Frame: 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. ]

7.  Secondary:   Comparison of Disease-specific HRQOL Change in Expanded Prostate Cancer Index Composite (EPIC); the Utilization of Sexual Medications/Devices Supplements the EPIC   [ Time Frame: Baseline, 6, 12, and 24 months, and 5 years ]

8.  Secondary:   The Utilization of Sexual Medications/Devices Questionaire   [ Time Frame: Baseline, 6, 12, and 24 months, and 5 years ]

9.  Secondary:   Change From Baseline in Assessment of Anxiety and Depression Using the HSCL-25   [ Time Frame: Baseline, 6 months, 12 months, 24 months, and 5 years ]

10.  Secondary:   EQ-5D Scores   [ Time Frame: Baseline, 6 months, 12 months, 24 months, and 5 years ]

11.  Secondary:   Assessment of Trade-off Between Disease-free Survival and Quality of Life.   [ Time Frame: From baseline to 5 years from the start of treatment ]

12.  Secondary:   Statistical Modeling of Genomic Biomarkers   [ Time Frame: Baseline biomarker collection will be used. Analysis occurs after the primary endpoint analysis. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

13.  Other Pre-specified:   Collection of Paraffin-embedded Tissue Block, Serum, Plasma, and Buffy Coat Cells for Future Translational Research Analyses   [ Time Frame: From baseline to 5 years from the start of treatment. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Wendy Seiferheld, M.S.
Organization: NRG Oncology
e-mail: seiferheldw@nrgoncology.org


Publications of Results:
McDonald AM, Dobelbower MC, Kim RY, et al.: Efficacy and rectal toxicity of hypofractionated radiation therapy with daily image guidance. [Abstract] J Clin Oncol 29 (Suppl 7): A-85, 2011.


Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00331773     History of Changes
Other Study ID Numbers: RTOG-0415
CDR0000481119
NCI-2009-00721 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Study First Received: May 30, 2006
Results First Received: November 29, 2016
Last Updated: February 28, 2017