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

Alternate Title

Phase II Randomized Neoadjuvant Study of Focused Microwave Thermotherapy Followed by Surgery Versus Surgery Alone in Women With Early-Stage Primary Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	Other	CELSION-10200202 OU-09532, NCT00036998

Trial Description

Purpose:

Microwave thermotherapy kills tumor cells by heating them to several degrees above body temperature.

Randomized phase II trial to compare the effectiveness of microwave thermotherapy before surgery to that of surgery alone in treating women who have stage I or stage II breast cancer.

Eligibility:

• At least 18 years old
• Planned lumpectomy and radiation therapy
• Measurable disease
• No metastatic cancer including skin metastases
• No bilateral breast cancer
• No cancer involving the nipple
• No inflammatory breast cancer
• 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 undergo a procedure to have sensors placed in and around the breast. Patients will then undergo microwave thermotherapy for up to 1 hour. Within 2 months, patients will undergo surgery to remove the tumor. Patients in group two will undergo surgery only. Patients will be evaluated at 1 month, 3 months, and periodically 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

Celsion Corporation

William Gannon, MD, Protocol chair		Ph: 410-290-5390 Email: wgannon@Celsion.com

Registry Information
Official Title		A Randomized Pivotal Clinical Trial In Breast Cancer Patients Of Pre-Operative Focal Microwave Thermotherapy Treatment For Early-Stage Breast Disease In Intact Breast
Trial Start Date		2001-08-12
Registered in ClinicalTrials.gov		NCT00036998
Date Submitted to PDQ		2002-03-26
Information Last Verified		2004-07-26

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