NCT01440010

TARGeted Intraoperative radioTherapy With INTRABEAM as a Boost for Breast Cancer - A Quality Control Registry

TARGeted Intraoperative radioTherapy With the INTRABEAM-System as an Advanced Boost in Patients With Breast Cancer - A Quality Control Registry in Germany (TARGIT BQR)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,133 (actual)
• Sponsor: Universitätsmedizin Mannheim · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Quality Control Registry for IORT used as an anticipiated boost with 20 Gy at the applicator surface followed by EBRT

Detailed description

Quality Control Registry of a standard treatment with intraoperative radiotherapy during breast conserving surgery with 20 Gy at the applicator surface as an advanced boost followed by a shortened external beam radiotherapy. This is a prospective phase IV study to evaluate real life data of IORT Boost. Study runs in Germany with 13 active centers recruiting. Due to the nature of the study (registry) there is no need for randomization. Inclusion of n = \>1000 patients is planned.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	IORT with 20 Gy	Intraoperative radiotherapy with the INTRABEAM System with 20 Gy

Timeline

• Start date: 2011-09-01
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2011-09-23
• Last updated: 2025-12-12
• Results posted: 2025-12-12

Locations

1 site across 1 country: Germany