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

Alternate Title

Phase III Randomized Study of Post-Surgical Stereotactic Radiosurgery Versus Whole-Brain Radiotherapy in Patients With Resected Metastatic Brain Metastases

Basic Trial Information

Trial Description

Purpose:

Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether stereotactic radiosurgery is more effective than whole-brain radiation therapy in treating patients with brain metastases that have been removed by surgery.

This randomized phase III trial studies how well stereotactic radiosurgery works compared to whole-brain radiation therapy in treating patients with brain metastases that have been removed by surgery.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• One to four brain metastases and has undergone surgery to remove one of the metastases
• No previous brain radiation therapy
• 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 (have an equal chance of being placed) to one of two treatment groups.

Patients in group one will undergo whole-brain radiation therapy once a day, 5 days a week, for approximately 3 weeks.

Patients in group two will undergo stereotactic radiosurgery.

Blood and urine samples will be collected at baseline and periodically during treatment for laboratory studies.

Patients will complete quality-of-life assessments at baseline and periodically during treatment.

After finishing treatment, patients will be evaluated for 5 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

North Central Cancer Treatment Group

Paul Brown, MD, Principal investigator		Ph: 713-563-2415; 800-392-1611

U.S.A.
Arizona
	Scottsdale
	Mayo Clinic Scottsdale
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
Colorado
	Englewood
	Swedish Medical Center
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Pueblo
	St. Mary - Corwin Regional Medical Center
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
Florida
	Jacksonville
	Mayo Clinic - Jacksonville
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
	Miami Beach
	CCOP - Mount Sinai Medical Center
		Laurie Blach	Ph:  305-674-2625
Michigan
	Kalamazoo
	West Michigan Cancer Center
		Clinical Trials Office - West Michigan Cancer Center	Ph:  269-373-7458
Minnesota
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
	Saint Cloud
	CentraCare Clinic - River Campus
		Donald Jurgens	Ph:  320-252-5131
Montana
	Billings
	Billings Clinic - Downtown
		Clinical Trials Office - Billings Clinic - Downtown	Ph:  800-996-2663
			Email: research@billingsclinic.org
New Hampshire
	Dover
	Seacoast Cancer Center at Wentworth - Douglass Hospital
		Arul Mahadevan	Ph:  603-742-8787
North Carolina
	Winston-Salem
	Wake Forest University Comprehensive Cancer Center
		Clinical Trials Office - Wake Forest University Comprehensive Cancer Center	Ph:  336-713-6771
North Dakota
	Bismarck
	Bismarck Cancer Center
		Edward Wos, DO	Ph:  701-323-5741
Ohio
	Akron
	Summa Center for Cancer Care at Akron City Hospital
		Clinical Trials Office - Akron City Hospital	Ph:  330-375-6101
Oklahoma
	Tulsa
	Natalie Warren Bryant Cancer Center at St. Francis Hospital
		Charles Stewart	Ph:  918-494-2273
Oregon
	Portland
	Legacy Good Samaritan Hospital & Comprehensive Cancer Center
		Clinical Trials Office - Legacy Good Samaritan Hospital & Comprehensive Cancer Center	Ph:  503-413-1742
	Salem
	Salem Hospital Regional Cancer Care Services
		Clinical Trials Office - Salem Hospital Regional Cancer Care Services	Ph:  503-561-2618
South Dakota
	Rapid City
	Rapid City Regional Hospital
		Michael Swartz	Ph:  605-719-2360
Wisconsin
	Green Bay
	St. Vincent Hospital Regional Cancer Center
		Clinical Trials Office - St. Vincent Hospital Regional Cancer Center	Ph:  920-433-8889
Canada
Ontario
	Hamilton
	Margaret and Charles Juravinski Cancer Centre
		Anthony Whitton	Ph:  905-387-9495
Quebec
	Sherbrooke
	CHUS-Hopital Fleurimont
		Laurence Masson-Cote	Ph:  819-346-1110

Registry Information
Official Title		A Phase III Trial of Post-Surgical Stereotactic Radiosurgery (SRS) Compared with Whole Brain Radiotherapy (WBRT) for Resected Metastatic Brain Disease
Trial Start Date		2011-07-08
Trial Completion Date		2014-03-12 (estimated)
Registered in ClinicalTrials.gov		NCT01372774
Date Submitted to PDQ		2011-06-01
Information Last Verified		2012-05-24
NCI Grant/Contract Number		CA-25224

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