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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2004 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00036998
First received: May 13, 2002
Last updated: November 5, 2013
Last verified: July 2004
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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:
No publications provided

ClinicalTrials.gov Identifier: NCT00036998     History of Changes
Other Study ID Numbers: CDR0000069347, CELSION-10200202, OU-09532
Study First Received: May 13, 2002
Last Updated: November 5, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 28, 2014