TARGeted Intraoperative radioTherapy With INTRABEAM as a Boost for Breast Cancer - A Quality Control Registry
Completed
- Conditions
- Breast Cancer
- Interventions
- Radiation: IORT with 50 kV x-rays, 20 Gy
- Registration Number
- NCT01440010
- Lead Sponsor
- Universitätsmedizin Mannheim
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1135
Inclusion Criteria
- Tumor diameter < 3,5 cm
- Informed consent
Exclusion Criteria
- No informed consent
- Tumor size > 3,5 cm
- No indication for a boost
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description IORT with 50 kV x-rays, 20 Gy IORT with 50 kV x-rays, 20 Gy Boost with 20 Gy during BCS, EBRT with 46-50 Gy
- Primary Outcome Measures
Name Time Method Local recurrence rate 5 years
- Secondary Outcome Measures
Name Time Method Toxicity, Overall survival 5 years LENT SOMA Scale for toxicity regular follow up
Trial Locations
- Locations (1)
University Medical Center Mannheim
🇩🇪Mannheim, Germany