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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01440010
Recruitment Status : Recruiting
First Posted : September 23, 2011
Last Update Posted : October 27, 2017
Information provided by (Responsible Party):
Frederik Wenz, Universitätsmedizin Mannheim

Brief Summary:
Quality control of IORT as a boost with 20 Gy followed by EBRT

Condition or disease Intervention/treatment
Breast Cancer Radiation: IORT with 50 kV x-rays, 20 Gy

Detailed Description:
Due to quality control of a standard treatment with intraoperative radiotherapy during breast conserving surgery with 20 Gy as an advanced boost followed by a shortened external beam radiotherapy. For all patients there is an informed consent for the irradiation and the data sampling in Germany. All data are collected anonymously at several centers in Germany and sent for analyses to the study center in Mannheim. Due to the nature of the study (registry) there is no need for randomization. Inclusion of n = 2000 patients is planned.

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official 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)
Study Start Date : September 2011
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: X-Rays

Group/Cohort Intervention/treatment
IORT with 50 kV x-rays, 20 Gy
Boost with 20 Gy during BCS, EBRT with 46-50 Gy
Radiation: IORT with 50 kV x-rays, 20 Gy
Intraoperative radiotherapy with the INTRABEAM System with 20 Gy

Primary Outcome Measures :
  1. Local recurrence rate [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Toxicity, Overall survival [ Time Frame: 5 years ]
    LENT SOMA Scale for toxicity regular follow up

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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 during surgery. Its feasibility was already shown. The IORT as a boost is included in several recommendations for breast cancer treatment (St. Gallen Conference 2011).

Inclusion Criteria:

  • Tumor diameter < 3,5 cm
  • Informed consent

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01440010

Contact: Frederik Wenz, MD +49 621 383 4960
Contact: Elena Sperk, MD +49 621 383 3530

University Medical Center Mannheim Recruiting
Mannheim, Germany, 68167
Contact: Elena Sperk, MD    +49 621 383 3530   
Contact: Anke Keller, MSc    +49 621 383 4493   
Principal Investigator: Frederik Wenz, Prof. Dr.         
Sub-Investigator: Elena Sperk,         
Sponsors and Collaborators
Universitätsmedizin Mannheim
Principal Investigator: Frederik Wenz, MD Universitätsmedizin Mannheim


Responsible Party: Frederik Wenz, Prof. Dr. med. Frederik Wenz, Universitätsmedizin Mannheim Identifier: NCT01440010     History of Changes
Other Study ID Numbers: TARGIT BQR
First Posted: September 23, 2011    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017

Keywords provided by Frederik Wenz, Universitätsmedizin Mannheim:
Breast cancer
Local recurrence
Quality Control Registry

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases