Phase II Study of Intra-operative Electron Irradiation and External Beam Irradiation After Lumpectomy in Patients With Stage T1N0M0 or T2N0M0 Breast Cancer
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 80
- Primary Endpoint
- Distant tumor control rate
Study Overview
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 trial is studying the side effects of giving radiation therapy during and after lumpectomy and to see how well it works in treating women with stage I or stage II breast cancer.
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 breast cancer treated with breast conservation therapy.
- To determine the local tumor control and distant tumor control rates in these patients.
- To determine the long-term side effects and cosmetic outcome of IOERT to the tumor bed and EBRT after lumpectomy in these patients.
OUTLINE: Patients undergo standard lumpectomy. Patients with negative lymph nodes undergo intraoperative electron radiotherapy to the tumor bed. Beginning 2-8 weeks after surgery, patients undergo whole breast external beam radiotherapy once daily for 24-27 fractions.
After completion of study treatment, patients are followed periodically for up to 8 years.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- Not provided
Outcomes
Primary Outcomes
Distant tumor control rate
Acute tolerability
Feasibility
Local tumor control rate
Cosmetic outcome
Long-term side effects
Secondary Outcomes
No secondary outcomes reported