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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 Palliative Percutaneous Cryoablation Versus Palliative External-Beam Radiotherapy in Patients With Painful Bone Metastases

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Active	18 and over	NCI	NCCTG-N06C6 N06C6, NCT00540969

Trial Description

Purpose:

Cryoablation kills cancer cells by freezing them. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. It is not yet known whether cryoablation is more effective than external-beam radiation therapy in treating painful bone metastases.

This randomized phase III clinical trial is studying cryoablation to see how well it works compared with external-beam radiation therapy in treating patients with painful bone metastases.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Current pain-reducing therapies are not working or cause side effects
• No previous cryoablation or radiation therapy for this cancer
• More than 4 weeks since radiopharmaceutical therapy
• More than 4 weeks since beginning a new chemotherapy regimen
• 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 (having an equal chance of being placed) to one of two treatment groups.

Patients in group one will undergo cryoablation using an approximately 10-, 5-, and 10-minute freeze-thaw-freeze cycle.

Patients in group two will undergo external-beam radiation therapy given as a single dose or as five separate treatments within 1 week.

Patients will be contacted by telephone and will assess pain 1 and 4 days after treatment, once a week in weeks 1-4, every 2 weeks in weeks 6-24, and every 4 weeks in weeks 28-36. Some patients may be offered the treatment they were not randomly assigned to receive after week 6.

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

Matthew Callstrom, MD, PhD, Protocol chair		Ph: 507-255-1222

U.S.A.
Alabama
	Birmingham
	Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
		Clinical Trials Office - Lurleen Wallace Comprehensive Cancer	Ph:  205-934-0309
Arizona
	Scottsdale
	Mayo Clinic Scottsdale
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
Florida
	Jacksonville
	Mayo Clinic - Jacksonville
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
Indiana
	Indianapolis
	Indiana University Melvin and Bren Simon Cancer Center
		Clinical Trials Office - Indiana University Cancer Center	Ph:  317-274-2552
Michigan
	Detroit
	Barbara Ann Karmanos Cancer Institute
		Clinical Trials Office - Barbara Ann Karmanos Cancer Institute	Ph:  313-576-9363
Minnesota
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
Wisconsin
	Milwaukee
	Medical College of Wisconsin Cancer Center
		Clinical Trials Office - Medical College of Wisconsin Cancer Center	Ph:  414-805-4380
	Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
		Clinical Trials Office - Vince Lombardi Cancer Clinic	Ph:  414-649-5717

Registry Information
Official Title		A Phase III Randomized Trial of Cryoablation vs. Radiation for the Palliation of Painful Bone Metastases
Trial Start Date		2008-02-08
Trial Completion Date		2009-03-01 (estimated)
Registered in ClinicalTrials.gov		NCT00540969
Date Submitted to PDQ		2007-09-21
Information Last Verified		2009-03-13