Phase II Study of Intra-operative Electron Irradiation and Hypofractionated External Beam Irradiation After Lumpectomy in Patients With Stage T1N0M0 or T2N0M0 Breast Cancer
21 Years
N/A
Female
Breast Cancer
Trial Information
Phase II Study of Intra-operative Electron Irradiation and Hypofractionated External Beam Irradiation After Lumpectomy in Patients With Stage T1N0M0 or T2N0M0 Breast Cancer
OBJECTIVES:
- To determine the feasibility and acute patient tolerance of intraoperative electron
irradiation (IOERT) and hypofractionated external-beam irradiation (HYPORT) after
lumpectomy for patients with stage I-IIA breast cancer treated with breast conservation
therapy.
- To determine the local tumor control and distant tumor control rates for patients with
stage I-IIA breast cancer treated with breast conservation therapy using IOERT and
HYPORT after lumpectomy.
- To determine the long-term side effects and cosmetic outcome of IOERT to tumor bed and
HYPORT after lumpectomy for patients with stage I-IIA breast cancer.
OUTLINE: Patients undergo lumpectomy per standard procedures. Patients undergo
intraoperative electron irradiation (IOERT) to the tumor bed right after completion of
lumpectomy with axillary lymph node dissection or sentinel lymph node biopsy.
Beginning 2-6 weeks after lumpectomy with axillary lymph node dissection/sentinel lymph node
sampling and IOERT, patients receive hypofractionated external-beam irradiation once daily
for 16 days.
After completion of study treatment, patients are followed at 3 months, every 6 months for 5
years, and then annually thereafter for 8 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed primary invasive breast carcinoma
- Stage I-IIA disease (T1, N0, M0 or T2, N0, M0)
- Pathologically determined single, discrete, and well-defined primary tumor ≤ 5
cm in diameter
- Pathologically negative surgical margins
- No multicentric disease and/or diffuse malignant appearing microcalcifications
- Micro-calcifications must be focal
- Specimen radiograph is required after lumpectomy for tumors associated with
malignant appearing calcifications to assure removal of all malignant
appearing calcifications
- Specimen radiograph is optional if the tumor appears as a discrete mass on
mammogram
- No axillary lymph node involvement
- No evidence of metastatic breast cancer
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Menopausal status not specified
- No pre-existing collagen vascular disease except rheumatoid arthritis that does not
require immunosuppressive therapy
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
- No prior irradiation to the area of planned radiation field
- No prior placement of breast prosthesis in the treated breast
- Concurrent hormonal therapy with external-beam irradiation allowed
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Toxicity: Up to 3 months post external beam radiation therapy
Outcome Time Frame:
3 months
Safety Issue:
Yes
Principal Investigator
William W. Wong, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000583007
NCT ID:
NCT00602108
Start Date:
January 2005
Completion Date:
August 2007
Related Keywords:
- Breast Cancer
- stage I breast cancer
- stage II breast cancer
- Breast Neoplasms
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