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Completed

NCT Number: NCT01440010

TARGeted Intraoperative radioTherapy With INTRABEAM as a Boost for Breast Cancer - A Quality Control Registry

Quality Control Registry for IORT used as an anticipiated boost with 20 Gy at the applicator surface followed by EBRT

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University Medical Center Mannheim

Mannheim, 68167, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Tumor diameter < 3,5 cm
  • Informed consent

Exclusion criteria

  • No informed consent
  • Tumor size > 3,5 cm
  • No indication for a boost

Treatment and study plan

IORT with 20 Gy

Radiation

Intraoperative radiotherapy with the INTRABEAM System with 20 Gy

Other names: Whole breast irradiation

Primary outcomes

  1. Number of Patients With Local Recurrence

    Time frame: 5 years

    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

Secondary outcomes

  1. Percentage of Patients With Chronic Higher Grade Fibrosis After IORT Boost

    Time frame: 84 months

    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).

Sponsors and collaborators

Lead sponsor

Universitätsmedizin Mannheim

Other

Registry information

Official study title

TARGeted Intraoperative radioTherapy With the INTRABEAM-System as an Advanced Boost in Patients With Breast Cancer - A Quality Control Registry in Germany (TARGIT BQR)

Acronym: TARGIT_BQR

Important dates

Study start
2011
Primary completion
2020
Study completion
2020
First posted
Sep 23, 2011
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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