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Microwave Thermotherapy in Treating Women With Stage I or Stage II Breast Cancer Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Microwave Thermotherapy in Treating Women With Stage I or Stage II Breast Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Microwave Thermotherapy in Treating Women With Stage I or Stage II Breast Cancer Clinical research trials and Microwave Thermotherapy in Treating Women With Stage I or Stage II Breast Cancer healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Microwave Thermotherapy in Treating Women With Stage I or Stage II Breast Cancer. Microwave Thermotherapy in Treating Women With Stage I or Stage II Breast Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Microwave Thermotherapy in Treating Women With Stage I or Stage II Breast Cancer clinical trial. Participants typically obtain the most effective healthcare available for their Microwave Thermotherapy in Treating Women With Stage I or Stage II Breast Cancer condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "M" Clinical Trials Conditions > Microwave Thermotherapy in Treating Women With Stage I or Stage II Breast Cancer  Microwave Thermotherapy in Treating Women With Stage I or Stage II Breast Cancer
Microwave Thermotherapy in Treating Women With Stage I or Stage II Breast Cancer
For Condition: stage 1 breast cancer,stage 2 breast cancer
Status: Recruiting
Sponsor(s): Celsion ,
Synopsis: RATIONALE: Microwave thermotherapy kills tumor cells by heating them to several degrees above body temperature. PURPOSE: Randomizedphase 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.
Details: 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. - 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WilliamGannon, Study Chair, Celsion
Breast Care Specialists, P.C. *Recruiting*
Norfolk, Virginia, 23510
United States
Recruiting Claire Carman 757-622-8032
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center *Recruiting*
Oklahoma City, Oklahoma, 73104
United States
Recruiting William Dooley 405-271-7867
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1781
United States
Recruiting Hernan Vargas 310-222-6715
St. Joseph Hospital Regional Cancer Center - Orange *Recruiting*
Orange, California, 92868
United States
Recruiting Jay Harness 714-744-8719
Mroz-Baier Breast Care Center *Recruiting*
Memphis, Tennessee, 38119
United States
Recruiting Christine Mroz 901-527-3391
Comprehensive Breast Center of Coral Springs *Recruiting*
Coral Springs, Florida, 33071
United States
Recruiting Mary Tomaselli 954-345-2718
Royal Bolton Hospital *Recruiting*
Bolton, Lancashire, England, BL4 0JR
United Kingdom
Recruiting John Winstanley 44-120-439-0397
Additional Information:
Study ID Numbers: CDR0000069347; CELSION-10200202,OU-09532
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00036998
Other Stage 1 Breast Cancer Studies:
1. Epirubicin and Tamoxifen With or Without Docetaxel in Treating Postmenopausal Women With Breast Cancer
2. Vaccine Therapy With Either Neoadjuvant or Adjuvant Chemotherapy and Adjuvant Radiation Therapy in Treating Women With p53-Overexpressing Stage II or Stage III Breast Cancer
3. Enhanced Ultrasound in Determining Extent of Disease in Women With Primary Breast Cancer
4. Chemotherapy in Treating Women Enrolled in the SWOG-8897 Clinical Trial
5. Tamoxifen Compared With LY353381 in Treating Women With Newly Diagnosed Breast Cancer
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Microwave Thermotherapy in Treating Women With Stage I or Stage II Breast Cancer
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