Quality Control Registry for IORT used as an anticipiated boost with 20 Gy at the applicator surface followed by EBRT
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.
Study Type
OBSERVATIONAL
Enrollment
1,133
Intraoperative radiotherapy with the INTRABEAM System with 20 Gy
University Medical Center Mannheim
Mannheim, Germany
Number of Patients With Local Recurrence
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
Time frame: 5 years
Percentage of Patients With Chronic Higher Grade Fibrosis After IORT Boost
Follow-up for toxicity assessment (LENT SOMA criteria: fibrosis, teleangiectasia, retraction, pain, breast edema, lymphedema, hyperpigmentation, ulceration) and oncological data took place before surgery, 6 weeks to 90 days after EBRT, 6 months after IORT, and then annually using standardized case report forms (CRFs).
Time frame: 84 months
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