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
Recruitment status was Active, not recruiting
Sponsor:
Celsion
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00036998
First received: May 13, 2002
Last updated: February 6, 2009
Last verified: July 2004
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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 |
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 | |
| 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: | February 6, 2009 |
| 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 June 17, 2013