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

November 5, 2013 updated by: Imunon

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Bolton, Lancashire, England, United Kingdom, BL4 0JR
        • Royal Bolton Hospital
  • United States
    • California
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA
      • Orange, California, United States, 92868
        • St. Joseph Hospital Regional Cancer Center - Orange
    • Florida
      • Coral Springs, Florida, United States, 33071
        • Comprehensive Breast Center of Coral Springs
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University Medical Center at University of Oklahoma Health Sciences Center
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Mroz-Baier Breast Care Center
    • Virginia
      • Norfolk, Virginia, United States, 23510
        • Breast Care Specialists, P.C.
    • Washington
      • Tacoma, Washington, United States, 98405

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imunon

Investigators

  • Study Chair: William E. Gannon, MD, Imunon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Study Registration Dates

First Submitted

May 13, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

November 6, 2013

Last Update Submitted That Met QC Criteria

November 5, 2013

Last Verified

July 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000069347
  • CELSION-10200202
  • OU-09532

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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