Microwave Thermotherapy in Treating Women With Stage I or Stage II Breast Cancer - Full Text View

Sponsored by:	Celsion
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00036998

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Procedure: conventional surgery Procedure: neoadjuvant therapy Procedure: thermal ablation therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control
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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Breast Diseases Cancer Surgery

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

August 2001

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00036998

Locations

United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
St. Joseph Hospital Regional Cancer Center - Orange
Orange, California, United States, 92868
United States, Florida
Comprehensive Breast Center of Coral Springs
Coral Springs, Florida, United States, 33071
United States, Oklahoma
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Mroz-Baier Breast Care Center
Memphis, Tennessee, United States, 38119
United States, Virginia
Breast Care Specialists, P.C.
Norfolk, Virginia, United States, 23510
United States, Washington

Tacoma, Washington, United States, 98405
United Kingdom, England
Royal Bolton Hospital
Bolton, Lancashire, England, United Kingdom, BL4 0JR

Sponsors and Collaborators

Celsion

Investigators

Study Chair:

William E. Gannon, MD

Celsion

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000069347, CELSION-10200202, OU-09532
Study First Received:	May 13, 2002
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00036998 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I breast cancer
stage II breast cancer

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on July 02, 2009