NCT00036998

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
2 countries

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2002

Completed
9 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

November 6, 2013

Status Verified

July 1, 2004

First QC Date

May 13, 2002

Last Update Submit

November 5, 2013

Conditions

Breast Cancer

Keywords

stage I breast cancerstage II breast cancer

Interventions

conventional surgeryPROCEDURE
neoadjuvant therapyPROCEDURE
thermal ablation therapyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (8)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

St. Joseph Hospital Regional Cancer Center - Orange

Orange, California, 92868, United States

Location

Comprehensive Breast Center of Coral Springs

Coral Springs, Florida, 33071, United States

Location

Oklahoma University Medical Center at University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Mroz-Baier Breast Care Center

Memphis, Tennessee, 38119, United States

Location

Breast Care Specialists, P.C.

Norfolk, Virginia, 23510, United States

Location

Unknown Facility

Tacoma, Washington, 98405, United States

Location

Royal Bolton Hospital

Bolton, Lancashire, England, BL4 0JR, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeutics

Study Officials

  • William E. Gannon, MD

    Imunon

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 13, 2002

First Posted

January 27, 2003

Study Start

August 1, 2001

Last Updated

November 6, 2013

Record last verified: 2004-07

Locations

US(7)GB(1)