Phase II Study of Intra-operative Electron Irradiation and Hypofractionated External Beam Irradiation After Lumpectomy in Patients With Stage T1N0M0 or T2N0M0 Breast Cancer
- 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
- 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.
Masking: Open Label, Primary Purpose: Treatment
Toxicity: Up to 3 months post external beam radiation therapy
William W. Wong, MD
United States: Federal Government