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

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial 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 Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00036998
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	August 2001

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms