Intensity-Modulated Radiation Therapy in Treating Patients With Prostate Cancer
Recruitment status was Recruiting
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.
Radiation: hypofractionated radiation therapy
Radiation: intensity-modulated radiation therapy
|Study Design:||Primary Purpose: Treatment|
|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|
- Late RTOG radiotherapy toxicity as assessed at 6, 12, 18, and 24 months and then annually thereafter [ Designated as safety issue: Yes ]
- Overall survival [ Designated as safety issue: No ]
- Local control [ Designated as safety issue: No ]
- PSA control [ Designated as safety issue: No ]
- Acute side effects as assessed weekly by the RTOG scoring system [ Designated as safety issue: Yes ]
- Quality of life [ Designated as safety issue: No ]
- Patterns of recurrence [ Designated as safety issue: No ]
|Study Start Date:||March 2000|
|Estimated Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|