An observational study in Breast Cancer, sponsored by Universitätsmedizin Mannheim. Completed at 1 site in Germany. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-12.
Sponsored by Universitätsmedizin Mannheim · Observational
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.
All patients with breast cancer and a tumor diameter \< 3,5 cm plannend for breast conserving surgery. Intraoperative radiotherapy (IORT) is applied as an advanced boost with 20 Gy at the applicator surface during surgery. Its feasibility was already shown. IORT as a boost is considered as one of several boost techniques in the S3-Leitlinie (national guideline) for breast cancer.
Exclusion Criteria:
Boost with 20 Gy during BCS, EBRT with 46-50 Gy
Radiation: IORT with 20 Gy
Intraoperative radiotherapy with the INTRABEAM System with 20 Gy
Also known as: Whole breast irradiation
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
| Milestone | IORT With 50 kV X-rays, 20 Gy |
|---|---|
| Started | 1133 |
| Completed | 902 |
| Not completed | 231 |
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
| participants | IORT Boost |
|---|---|
| Number of Patients With Local Recurrence | 10 |
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).
| Participants | IORT Boost |
|---|---|
| Percentage of Patients With Chronic Higher Grade Fibrosis After IORT Boost | 132 |
Collected over 5 years. Non-serious events are listed at a 4% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IORT Boost With 20 Gy and Standard Whole Breast Irradition | 16/902 (1.8%) | 0/902 (0%) | 83/902 (9.2%) |
| Event | IORT Boost With 20 Gy and Standard Whole Breast Irradition |
|---|---|
| Palpable seromaSkin and subcutaneous tissue disorders | 83/902 |
| ErythemaSkin and subcutaneous tissue disorders | 40/902 |
902 with complete paper work and minimum follow-up data set
| Age, Continuous(years) | IORT Boost With 20 Gy and Standard Whole Breast Irradition |
|---|---|
| Median | 61 (30 to 90) |
| Sex: Female, Male(Participants) | IORT Boost With 20 Gy and Standard Whole Breast Irradition |
|---|---|
| Female | 902 |
| Male | 0 |
| Race and Ethnicity Not Collected(Participants) | IORT Boost With 20 Gy and Standard Whole Breast Irradition |
|---|
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Universitätsmedizin Mannheim