TARGeted Intraoperative radioTherapy With the INTRABEAM-System as an Advanced Boost in Patients With Breast Cancer - A Quality Control Registry in Germany (TARGIT BQR)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Universitätsmedizin Mannheim
- Enrollment
- 1133
- Locations
- 1
- Primary Endpoint
- Number of Patients With Local Recurrence
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief 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.
Investigators
Elena Sperk, MD
Senior Consultant, Managing Director Clinical Trials Unit Mannheim Cancer Center
Universitätsmedizin Mannheim
Eligibility Criteria
Inclusion Criteria
- •Tumor diameter \< 3,5 cm
- •Informed consent
Exclusion Criteria
- •No informed consent
- •Tumor size \> 3,5 cm
- •No indication for a boost
Outcomes
Primary Outcomes
Number of Patients With Local Recurrence
Time Frame: 5 years
The follow-up was carried out every six months for the first two years, and then once a year. The follow-up always included a mammography in addition to a clinical examination. Kaplan-Meier-estimates were done to calculate the local recurrence rate
Secondary Outcomes
- Percentage of Patients With Chronic Higher Grade Fibrosis After IORT Boost(84 months)