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

Alternate Title

Phase II/III Randomized Study of Prophylactic Cranial Irradiation in Patients With Limited Stage Small Cell Lung Cancer (phase III closed to accrual as of 12/31/05)

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III, Phase II	Treatment	Closed	Not specified	NCI	RTOG-0212 RTOG 0212, NCT00057746

Trial Description

Purpose:

Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which radiation therapy regimen is more effective in preventing brain metastases in patients with limited-stage small cell lung cancer.

This randomized phase II/III trial is studying how well brain irradiation works and compares three different brain irradiation regimens in preventing brain metastases in patients with limited-stage small cell lung cancer.

Eligibility:

Eligibility criteria include the following:

• No brain metastases or lung metastases
• At least 1 week since chemotherapy
• No previous radiation therapy to the head or neck
• 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 three groups. Patients in group one will undergo brain irradiation 5 days a week for 2 weeks. Patients in group two will undergo brain irradiation 5 days a week for 2.6 weeks. Patients in group three will undergo brain irradiation twice a day 5 days a week for 3.4 weeks. Quality of life will be assessed periodically. Patients will be evaluated every 6 months for 1 year and once a year for 3 years.

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

Radiation Therapy Oncology Group

Aaron Wolfson, MD, Protocol chair		Ph: 305-243-4210 Email: awolfson@med.miami.edu

Registry Information
Official Title		A Phase II/III Randomized Trial Of Two Dose Schedules For Delivering Prophylactic Cranial Irradiation For Patients With Limited Disease Small Cell Lung Cancer
Trial Start Date		2003-02-19
Trial Completion Date		2009-08-12 (estimated)
Registered in ClinicalTrials.gov		NCT00057746
Date Submitted to PDQ		2002-10-28
Information Last Verified		2008-10-23
NCI Grant/Contract Number		CA21661

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