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Sponsored by: |
Celsion |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00036985 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Microwave thermotherapy kills tumor cells by heating them to several degrees above body temperature. Combining chemotherapy with microwave thermotherapy before surgery may shrink the tumor so that it can be removed during surgery.
PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy with or without microwave thermotherapy before surgery in treating women who have locally advanced breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: cyclophosphamide Drug: doxorubicin hydrochloride 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 To Assess The Efficacy Of Pre-Operative Focused Microwave Thermotherapy Treatment Combined With Pre-Operative Chemotherapy For Cytoreduction Of Advanced Breast Cacer In Intact Breast |
Study Start Date: | August 2001 |
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to tumor size (T2 vs T3). Patients are randomized to 1 of 2 treatment arms.
During courses 1 and 2 only, patients undergo focused microwave thermotherapy on day 1 of chemotherapy (or within 36 hours after chemotherapy). Patients undergo ultrasound-guided placement of a microwave sensor and a temperature probe (before or after compression of the breast) and external placement of 2 large opposing microwave emitters and up to 7 skin temperature sensors on the compressed breast. Patients then receive focused microwave thermotherapy that slowly heats the primary breast tumor and deep proximal breast tissue. In the absence of any unacceptable toxicity, a target tumor temperature of 43-47° C is reached and maintained for an equivalent thermal dose of 80-120 minutes.
Patients are followed at 30 and 90 days.
PROJECTED ACCRUAL: A total of 280-312 patients (140-156 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 locally advanced primary breast cancer
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 |
Study Chair: | William E. Gannon, MD | Celsion |
Study ID Numbers: | CDR0000069346, CELSION-10200201, OU-09533 |
Study First Received: | May 13, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00036985 |
Health Authority: | United States: Federal Government |
stage IIIA breast cancer |
Skin Diseases Breast Neoplasms Cyclophosphamide Doxorubicin Breast Diseases |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |
Neoplasms Neoplasms by Site Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |