Electronic Xoft Intersociety Brachytherapy Trial: Electronic Brachytherapy (EBT) For Treatment of Early Stage Breast Cancer

Study Summary

PRINCIPAL INVESTIGATORS * Rakesh Patel, MD- Radiation Oncologist * Peter Beitsch, MD- Breast Surgeon REGISTRY DESIGN * Multicenter, non-randomized, post market registry of intracavitary accelerated partial breast irradiation in appropriately selected patients. SAMPLE SIZE AND SITES: * Approximately 400 patients may be enrolled. * Up to 100 qualified U.S. sites may participate in this registry. ENDPOINTS: 1. PRIMARY ENDPOINTS * Subcutaneous Toxicities - The incidence of signs and symptoms of subcutaneous toxicities will be recorded at the following follow-up visits; at six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year. * Skin Toxicities - Specific toxicities that can result from radiation therapy will be recorded at each follow-up visit. The Common Terminology Criteria for Adverse Events will be used and to be recorded at each follow-up visits; at one (1) month, six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year. * Cosmetic Outcome - Cosmetic outcome will be recorded at the following follow-up visits; at one (1) month, six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year. Cosmetic outcome will be assessed and graded in two ways: * Patient Quality of Life Questionnaire - A Quality of Life Questionnaire (QOL) will be completed at the following visits; at one (1) month, six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year. 2. SECONDARY ENDPOINTS * Local-regional Breast Failure - The secondary efficacy endpoint is ipsilateral breast failure at five (5) years. This includes: * Ipsilateral recurrence within the initially treated volume. (Within the tumor bed) * Ipsilateral recurrence of cancer outside of the initially treated volume. (Elsewhere Failure) * Axillary nodal recurrence * Survival - to be recorded at each follow-up visit * Overall Survival * Disease Free S

Conditions Studied

Interventions

• RADIATION Electronic Brachytherapy
• RADIATION Intracavitary accelerated partial breast irradiation

Study Locations (8)