Status:
COMPLETED
Phase II Study of Intra-Operative Electron Irradiation and External Beam Irradiation After Lumpectomy in Patients With T1N0M0 and T2N0M0 Breast Cancer
Lead Sponsor:
Mayo Clinic
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The study is being done to determine the tolerance to single fraction intra-operative electron irradiation (IOERT) and external beam photon irradiation (EBRT) following lumpectomy for T1/T2N0M0 breast...
Eligibility Criteria
Inclusion
- Eligibility:
- Histologically proven primary invasive breast carcinoma.
- Tumor pathologically determined \<= 5cm in diameter.
- Single, discrete, well-defined primary tumor.
- Any micro-calcifications must be focal. A specimen radiograph is required after lumpectomy to assure removal of all malignant appearing calcifications.
- Pathologically negative surgical margins.
- Axillary lymph node status can be determined by level I and II lymph node dissection or sentinel lymph node sampling.
- ECOG performance status 0-2.
- Contraindications:
- Multicentric disease and/or diffuse malignant appearing microcalcifications.
- Evidence of metastatic breast cancer.
- Axillary lymph node involvement.
- Pre-existing collagen vascular disease except rheumatoid arthritis that does not require immunosuppressive therapy.
- Prior irradiation to the ara of planned radiation field.
- Pregnant or lactating women.
Exclusion
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT01215162
Start Date
January 1 2003
End Date
January 1 2013
Last Update
April 3 2014
Active Locations (1)
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1
Mayo Clinic
Scottsdale, Arizona, United States