Microwave Thermotherapy in Treating Women With Stage I or Stage II Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00036998
- Lead Sponsor
- Imunon
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* Compare the safety and efficacy of preoperative focused microwave thermotherapy followed by surgery vs surgery alone in women with early-stage primary breast cancer.
* Compare the reduction of tumor cells at surgical margins and second incision rates in women treated with these regimens.
* Compare the percentage of pathological cell death in women treated with these regimens.
* Compare the amount of surgically removed breast and tumor tissue in women treated with these regimens.
* Compare the measurement of the extent tumor margins of the surgically removed breast and tumor tissue in women treated with these regimens.
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.
* Arm I: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 undue heating of the skin, a tumor temperature of 48-52° C is targeted and maintained for an equivalent thermal dose of 140-180 minutes.
Within 60 days of thermotherapy, patients undergo lumpectomy.
* Arm II: Patients undergo lumpectomy only. Patients are followed at 30 and 90 days after surgery, and then at the discretion of the physician.
PROJECTED ACCRUAL: A total of 200-222 patients (100-111 per treatment arm) will be accrued for this study.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Mroz-Baier Breast Care Center
🇺🇸Memphis, Tennessee, United States
Breast Care Specialists, P.C.
🇺🇸Norfolk, Virginia, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
St. Joseph Hospital Regional Cancer Center - Orange
🇺🇸Orange, California, United States
Royal Bolton Hospital
🇬🇧Bolton, Lancashire, England, United Kingdom
Comprehensive Breast Center of Coral Springs
🇺🇸Coral Springs, Florida, United States
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States