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One-Time radiation during surgery shows promise in breast cancer control

NCT ID NCT01440010

Disease control Sponsor: Universitätsmedizin Mannheim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested giving a single, targeted dose of radiation directly to the tumor site during breast cancer surgery, followed by standard radiation. Over 1,100 patients with small tumors were followed for years to see if the cancer came back. The goal was to improve local control and reduce side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

1,133 people

The number who actually took part.

Started

Sep 2011

Finished

Dec 2020

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Tumor diameter \< 3,5 cm * Informed consent Exclusion Criteria: * No informed consent * Tumor size \> 3,5 cm * No indication for a boost

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • University Medical Center Mannheim

    Mannheim, 68167, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.