Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Microwave Thermotherapy in Treating Women With Stage I or Stage II Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	Other	CELSION-10200202 OU-09532, NCT00036998

Objectives

1. Compare the safety and efficacy of preoperative focused microwave thermotherapy followed by surgery vs surgery alone in women with early-stage primary breast cancer.
2. Compare the reduction of tumor cells at surgical margins and second incision rates in women treated with these regimens.
3. Compare the percentage of pathological cell death in women treated with these regimens.
4. Compare the amount of surgically removed breast and tumor tissue in women treated with these regimens.
5. Compare the measurement of the extent tumor margins of the surgically removed breast and tumor tissue in women treated with these regimens.

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

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

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/mm³ (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

Expected Enrollment

A total of 200-222 patients (100-111 per treatment arm) will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Celsion Corporation

William Gannon, MD, Protocol chair		Ph: 410-290-5390 Email: wgannon@Celsion.com

Registry Information
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
Trial Start Date		2001-08-12
Registered in ClinicalTrials.gov		NCT00036998
Date Submitted to PDQ		2002-03-26
Information Last Verified		2004-07-26

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