Phase II Study of Intra-operative Electron Irradiation and External Beam Irradiation After Lumpectomy in Patients With Stage T1N0M0 or T2N0M0 Breast Cancer
- 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.
Masking: Open Label, Primary Purpose: Treatment
William W. Wong, MD
United States: Federal Government