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Sponsored by: |
Celsion |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00036998 |
RATIONALE: Microwave thermotherapy kills tumor cells by heating them to several degrees above body temperature.
PURPOSE: 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.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Procedure: conventional surgery Procedure: neoadjuvant therapy Procedure: thermal ablation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
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 |
Study Start Date: | August 2001 |
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to tumor classification (T1 vs T2) and participating center. Patients are randomized to 1 of 2 treatment arms.
Within 60 days of thermotherapy, patients undergo lumpectomy.
PROJECTED ACCRUAL: A total of 200-222 patients (100-111 per treatment arm) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary breast cancer by core needle biopsy
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, California | |
Jonsson Comprehensive Cancer Center, UCLA | |
Los Angeles, California, United States, 90095-1781 | |
St. Joseph Hospital Regional Cancer Center - Orange | |
Orange, California, United States, 92868 | |
United States, Florida | |
Comprehensive Breast Center of Coral Springs | |
Coral Springs, Florida, United States, 33071 | |
United States, Oklahoma | |
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center | |
Oklahoma City, Oklahoma, United States, 73104 | |
United States, Tennessee | |
Mroz-Baier Breast Care Center | |
Memphis, Tennessee, United States, 38119 | |
United States, Virginia | |
Breast Care Specialists, P.C. | |
Norfolk, Virginia, United States, 23510 | |
United States, Washington | |
Tacoma, Washington, United States, 98405 | |
United Kingdom, England | |
Royal Bolton Hospital | |
Bolton, Lancashire, England, United Kingdom, BL4 0JR |
Study Chair: | William E. Gannon, MD | Celsion |
Study ID Numbers: | CDR0000069347, CELSION-10200202, OU-09532 |
Study First Received: | May 13, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00036998 |
Health Authority: | United States: Federal Government |
stage I breast cancer stage II breast cancer |
Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site |