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Sponsors and Collaborators: |
Fox Chase Cancer Center National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00062309 |
RATIONALE: Radiation therapy uses high-energy x-rays and other sources of radiation to kill tumor cells. It is not yet known which radiation therapy regimen is more effective in treating prostate cancer.
PURPOSE: This randomized phase III trial is comparing two different regimens of radiation therapy to see how well they work in treating patients with stage II or stage III prostate cancer.
Condition | Intervention | Phase |
Prostate Cancer |
Procedure: radiation therapy |
Phase III |
MedlinePlus related topics: | Cancer Prostate Cancer |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Phase III Intensity Modulated Radiotherapy Dose Escalation Trial for Prostate Cancer Using Hypofractionation |
Estimated Enrollment: | 300 |
Study Start Date: | June 2002 |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are stratified according to pretreatment prostate-specific antigen (no greater than 10 ng/mL vs greater than 10 to 20 ng/mL vs greater than 20 ng/mL), Gleason score (5-7 vs 8-10), and risk status (high risk vs intermediate risk). Patients are randomized to 1 of 2 treatment arms.
Patients with high-risk disease also undergo androgen deprivation therapy for 2 years.
Quality of life is assessed at baseline, every 6 months for 1 year, and then annually for 4 years.
Patients are followed at 3 months, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study within 3 years.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
One of the following criteria must be met:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, Pennsylvania | |||||
Fox Chase Cancer Center - Philadelphia | |||||
Philadelphia, Pennsylvania, United States, 19111-2497 |
Fox Chase Cancer Center |
National Cancer Institute (NCI) |
Study Chair: | Alan Pollack, MD, PhD | Fox Chase Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Pollack A, Bae K, Khor LY, et al.: Stability of tumor biomarkers in archival tissue from men treated with radiotherapy for prostate cancer: an analysis of RTOG 92-02 and Fox Chase randomized trials. [Abstract] Int J Biol Markers 22 (1): 72-3, 2006.
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Study ID Numbers: | CDR0000304712, FCCC-02602 |
First Received: | June 5, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00062309 |
Health Authority: | United States: Federal Government |
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