Status:
COMPLETED
Radiation Therapy During and After Lumpectomy in Treating Women With Stage I or Stage II Breast Cancer
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-99 years
Phase:
PHASE2
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy during and after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II ...
Detailed Description
OBJECTIVES: * To determine the feasibility and acute tolerability of intraoperative electron radiotherapy (IOERT) and external-beam radiotherapy (EBRT) after lumpectomy in women with stage I or II br...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed primary invasive breast carcinoma, meeting the following criteria:
- Stage I or II disease (T1-T2, N0, M0)
- Tumor pathologically determined to be ≤ 5 cm in diameter
- Single, discrete, well-defined primary tumor
- No multicentric disease and/or diffuse malignant appearing microcalcifications
- Any microcalcifications must be focal
- Specimen radiograph is required after lumpectomy to assure removal of all malignant appearing calcifications
- No axillary lymph node involvement
- Axillary lymph node status can be determined by level I and II lymph node dissection or sentinel lymph node sampling
- Must have pathologically negative surgical margins
- No evidence of metastatic breast cancer
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Menopausal status not specified
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No pre-existing collagen vascular disease except rheumatoid arthritis that does not require immunosuppressive therapy
- PRIOR CONCURRENT THERAPY:
- No prior irradiation to the area of planned radiation field
- Concurrent hormone therapy allowed
Exclusion
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 21 2013
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00647582
Start Date
October 1 2002
End Date
December 21 2013
Last Update
March 21 2018
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