Know Cancer

or
forgot password

A Randomized Pivotal Clinical Trial In Breast Cancer Patients Of Pre-Operative Focal Microwave Thermotherapy Treatment For Early-Stage Breast Disease In Intact Breast


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

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, UCLALos Angeles, California  90095-1781
Oklahoma University Medical Center at University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73126
St. Joseph Hospital Regional Cancer Center - OrangeOrange, California  92868-3849
Seattle, Washington  98195
Comprehensive Breast Center of Coral SpringsCoral Springs, Florida  33071
Mroz-Baier Breast Care CenterMemphis, Tennessee  38119
Breast Care Specialists, P.C.Norfolk, Virginia  23510