Intensity-Modulated Radiation Therapy in Treating Patients With Prostate Cancer
|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
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|