A Randomized Pivotal Clinical Trial In Breast Cancer Patients Of Pre-Operative Focal Microwave Thermotherapy Treatment For Early-Stage Breast Disease In Intact Breast
18 Years
N/A
Female
Breast Cancer
Trial Information
A Randomized Pivotal Clinical Trial In Breast Cancer Patients Of Pre-Operative Focal Microwave Thermotherapy Treatment For Early-Stage Breast Disease In Intact Breast
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed primary breast cancer by core needle biopsy
- T1a, b, c, or T2
- Diagnosis not made with a lumpectomy or incisional biopsy
- Candidate for breast conservation surgery (lumpectomy/radiotherapy)
- Tumor measurable by breast ultrasound
- No metastatic disease, including skin metastases
- No bilateral breast cancer
- No high-probability of extensive intraductal disease in situ
- No clinical fixation to the pectoralis major muscle or skin
- No involvement of the nipple
- No inflammatory breast cancer
- No multicentric disease
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- Karnofsky 70-100%
Life expectancy:
- At least 6 months
Hematopoietic:
- Platelet count at least 100,000/mm^3 (no thrombocytopenia)
- No bleeding disorders
Hepatic:
- PT, INR, and PTT less than 1.5 times normal
- Bilirubin no greater than 2.0 mg/dL
- Transaminases no greater than 2 times normal
- No coagulopathy
- No liver disease
Renal:
- BUN less than 30 mg/dL
- Creatinine less than 1.9 mg/dL
- No renal insufficiency
Cardiovascular:
- No pacemakers or defibrillators
- No clinically significant heart disease
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use 2 forms of effective contraception, including 1 barrier
method
- Able to tolerate prone position and breast compression
- No breast implants
- No prior collagen vascular disease
- No other factor or condition (other than tumor size) that would preclude lumpectomy
- No mental condition that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
Surgery:
- See Disease Characteristics
Other:
- No prior participation in this study
- More than 30 days since prior participation in another clinical study
- No concurrent anticoagulants
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
William E. Gannon, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Celsion
Authority:
United States: Federal Government
Study ID:
CDR0000069347
NCT ID:
NCT00036998
Start Date:
August 2001
Completion Date:
Related Keywords:
- Breast Cancer
- stage I breast cancer
- stage II breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
| Oklahoma University Medical Center at University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73126 |
| St. Joseph Hospital Regional Cancer Center - Orange | Orange, California 92868-3849 |
| Seattle, Washington 98195 | |
| Comprehensive Breast Center of Coral Springs | Coral Springs, Florida 33071 |
| Mroz-Baier Breast Care Center | Memphis, Tennessee 38119 |
| Breast Care Specialists, P.C. | Norfolk, Virginia 23510 |
