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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 1,133 is above the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Universitätsmedizin Mannheim is the lead sponsor of 78 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 |
|---|
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Sep 2011 to primary completion in Dec 2020, 111 months.
Results were first posted in Dec 2025, 4 years 11 months after primary completion.
Of 1,191 non-industry observational studies under Breast Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 139. This study's 111 months is above that.
Counting every sponsor, half of 1,380 studies reached it within 55 months; a quarter within 25 and three quarters within 126.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Universitätsmedizin Mannheim