Intensity-Modulated Radiation Therapy in Treating Patients With 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: NCT00946543|
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : July 27, 2009
Last Update Posted : August 26, 2013
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This phase I trial is studying the best dose of intensity-modulated radiation therapy in treating patients with prostate cancer.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: hypofractionated radiation therapy Radiation: intensity-modulated radiation therapy||Phase 1|
- To test the feasibility of delivering hypofractionated intensity-modulated radiotherapy to the prostate and pelvic nodes of patients with prostate cancer.
- To determine the optimal dose level of this treatment regimen to be used in future studies.
OUTLINE: Patients are stratified according to small bowel total volume (low small bowel volume < 450 cc vs high small bowel volume ≥ 450 cc).
Patients undergo hypofractionated intensity-modulated radiotherapy to the prostate and pelvis for 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for 5 years and then annually thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||198 participants|
|Official Title:||A Phase I Dose Escalation Study of the Use of Intensity Modulated Radiotherapy (IMRT) to Treat Prostate and Pelvic Nodes in Patients With Prostate Cancer - Pelvic IMRT for Prostate Cancer|
|Study Start Date :||March 2000|
|Estimated Primary Completion Date :||March 2010|
- Late RTOG radiotherapy toxicity as assessed at 6, 12, 18, and 24 months and then annually thereafter
- Overall survival
- Local control
- PSA control
- Acute side effects as assessed weekly by the RTOG scoring system
- Quality of life
- Patterns of recurrence
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00946543
|Institute of Cancer Research - Chelsea||Recruiting|
|London, England, United Kingdom, SW3 6JB|
|Contact: Contact Person 44-20-7352-8133|
|Institute of Cancer Research - Sutton||Recruiting|
|Sutton, England, United Kingdom, SM2 5NG|
|Contact: Contact Person 44-181-643-8901|
|Royal Marsden - Surrey||Recruiting|
|Sutton, England, United Kingdom, SM2 5PT|
|Contact: David P. Dearnaley, MD, FRCP, FRCR 44-20-8661-3271|
|Principal Investigator:||David P. Dearnaley, MD, FRCP, FRCR||Royal Marsden NHS Foundation Trust|