Single Fraction Intraoperative Radiotherapy

NACompletedINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

February 29, 2012

Primary Completion Date

February 29, 2016

Study Completion Date

February 28, 2022

Conditions
Invasive Ductal and Invasive Lobular Breast CarcinomaStage 0 Breast CarcinomaStage I Breast CarcinomaStage II Breast Carcinoma
Interventions
PROCEDURE

Intraoperative Radiotherapy

Intraoperative radiotherapy (IORT) is delivered after completion of the lumpectomy and sentinel node procedure. IORT is performed on mobile or fixed linacs with variable electron energies in the range of 6-12 MeV prescribed to a dose of 21 Gy, with the prescription dose covering at least 90% of the Planning Target Volume (PTV). PTV is defined as a 3D volume of 1-2 cm beyond the former macroscopic tumor edge (excluding skin, limit to anterior rib surface: 5 Gy). The choice of electron energy as well as the cone applicator size has to account for minimum PTV requirements. Tissue depth measurement will be documented by intraoperative sonography.

Trial Locations (1)

92868

St. Joseph Hospital of Orange, Orange

All Listed Sponsors
lead

St. Joseph Hospital of Orange

OTHER

NCT01688388 - Single Fraction Intraoperative Radiotherapy | Biotech Hunter | Biotech Hunter