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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Randomized Study of Conventional Versus Hypofractionated Intensity-Modulated Radiotherapy in Patients With Stage II or III Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	Not specified	NCI	FCCC-02602 NCT00062309

Trial Description

Purpose:

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.

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.

Eligibility:

Eligibility criteria include the following:

• No metastatic cancer
• No more than 4 months of androgen ablation therapy
• No previous radiation therapy to the pelvis
• No previous or scheduled radical prostatectomy
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned to one of two groups.

Patients in group one will receive standard radiation therapy 5 days a week for up to 7.5 weeks.

Patients in group two will receive high- dose radiation therapy 5 days a week for up to 5 weeks.

Some patients may also receive androgen ablation therapy for 2 years. Quality of life will be assessed periodically. Patients will be evaluated at 3 months, every 6 months for 2 years, and once a year thereafter.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Fox Chase Cancer Center - Philadelphia

Alan Pollack, MD, PhD, Protocol chair		Ph: 215-728-2940; 888-369-2427 Email: alan.pollack@fccc.edu

Registry Information
Official Title		A Phase III Intensity Modulated Radiotherapy Dose Escalation Trial for Prostate Cancer Using Hypofractionation
Trial Start Date		2002-06-17
Registered in ClinicalTrials.gov		NCT00062309
Date Submitted to PDQ		2003-05-06
Information Last Verified		2006-08-15
NCI Grant/Contract Number		CA06927

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