BACKGROUND: The principal objective of the targeted intraoperative radiation therapy trial was to determine whether single-fraction intraoperative radiotherapy (IORT) targeted to the tumor bed provides equivalent local control compared with whole-breast irradiation in patients with early-stage invasive breast cancer. METHODS: Patients were randomized equally to IORT versus whole breast irradiation. Patients randomized to IORT received tumor bed irradiation prescribed at 20 Gy to the surgical margins using soft x-rays (50 kV) delivered with the Intrabeam Photon Radiosurgery System (Zeiss Inc, Oberkochen, Germany). Patients randomized to whole-breast irradiation received radiotherapy postoperatively. Prior wide local excision was allowed. Patients randomized to IORT after initial breast-conserving surgery received IORT at a second operation. RESULTS:A total of 779 patients were accrued at 16 institutions internationally. Five hundred sixty patients were randomized before initial breast-conserving surgery. One hundred eighty-three patients were randomized after initial breast-conserving surgery. The median follow-up time was 359 days. CONCLUSION: Targeted IORT allowed the entire dose of radiotherapy to be administered in a single fraction at the time of breast-conserving surgery, thus avoiding the need for repeated radiotherapy treatments or placement of indwelling radiotherapy devices.
RCT Entities:
BACKGROUND: The principal objective of the targeted intraoperative radiation therapy trial was to determine whether single-fraction intraoperative radiotherapy (IORT) targeted to the tumor bed provides equivalent local control compared with whole-breast irradiation in patients with early-stage invasive breast cancer. METHODS:Patients were randomized equally to IORT versus whole breast irradiation. Patients randomized to IORT received tumor bed irradiation prescribed at 20 Gy to the surgical margins using soft x-rays (50 kV) delivered with the Intrabeam Photon Radiosurgery System (Zeiss Inc, Oberkochen, Germany). Patients randomized to whole-breast irradiation received radiotherapy postoperatively. Prior wide local excision was allowed. Patients randomized to IORT after initial breast-conserving surgery received IORT at a second operation. RESULTS: A total of 779 patients were accrued at 16 institutions internationally. Five hundred sixty patients were randomized before initial breast-conserving surgery. One hundred eighty-three patients were randomized after initial breast-conserving surgery. The median follow-up time was 359 days. CONCLUSION: Targeted IORT allowed the entire dose of radiotherapy to be administered in a single fraction at the time of breast-conserving surgery, thus avoiding the need for repeated radiotherapy treatments or placement of indwelling radiotherapy devices.
Authors: Claire M B Holloway; Alexandra Easson; Jaime Escallon; Wey Liang Leong; May Lynn Quan; Michael Reedjik; Frances C Wright; David R McCready Journal: Can J Surg Date: 2010-08 Impact factor: 2.089
Authors: Randall J Kimple; Nancy Klauber-DeMore; Cherie M Kuzmiak; Dag Pavic; Jun Lian; Chad A Livasy; WingKeung M Chiu; Dominic T Moore; Carolyn I Sartor; David W Ollila Journal: Ann Surg Oncol Date: 2011-04 Impact factor: 5.344
Authors: U Veronesi; R Orecchia; A Luini; V Galimberti; G Gatti; M Intra; P Veronesi; M C Leonardi; M Ciocca; R Lazzari; P Caldarella; N Rotmensz; C Sangalli; L S Silva; D Sances Journal: Ecancermedicalscience Date: 2008-02-26
Authors: Ronald Rivera; Virginia Smith-Bronstein; Sylvia Villegas-Mendez; Jessica Rayhanabad; Pulin Sheth; Afshin Rashtian; Dennis R Holmes Journal: Radiol Res Pract Date: 2012-02-26