TARGIT-E(Elderly) Prospective Phase II Study of Intraoperative Radiotherapy (IORT) in Elderly Patients With Small Breast Cancer
Patients ≥ 70 years with small, low-risk breast cancer who are operated but not irradiated
show local relapse rates around 4% after 4 years. With adjuvant whole breast radiotherapy
(WBRT) the local relapse rate drops to 1% after 4 years under Tamoxifen (Hughes et al 2004).
It has been demonstrated (Polgar et al. 2007, Vaidya et al. 2010) that the efficacy of
radiation of the tumor bed only in a selected group can be non-inferior to WBRT. The TARGIT
E study should confirm the efficacy of a single dose of intraoperative radiotherapy (IORT)
in a well selected group of elderly patients with small breast cancer and absence of risk
factors. In presence of risk factors postoperative WBRT will be added to complete the
radiotherapeutic treatment according to international guidelines.
Endpoints are the local relapse rate (within 2 cm of the tumor bed), ipsilateral relapse,
cancer-specific and overall survival and contralateral breast cancer as well as
documentation of quality of life and cosmetic outcome. The expected local relapse rates are
0.5/1/1.5% after 2.5/5/7.5 years, respectively.
Discontinuation of the trial is scheduled if rates of local relapse rates rise to 3/4/6%
after 2.5/5/7.5 years. Power calculations result in 265 patients with a calculated loss to
follow-up of 20%, an alpha of 0.05 and a beta 0.1. Only centers with access to the
Intrabeam® system (Carl Zeiss) can recruit patients into the trial.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of local relapse (within 2cm of the initial tumor bed)
Frederik Wenz, Prof. Dr.
Medical Center Mannheim
Germany: Federal Office for Radiation Protection