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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by Universitätsmedizin Mannheim
Information provided by (Responsible Party):
Frederik Wenz, Universitätsmedizin Mannheim Identifier:
First received: September 22, 2011
Last updated: January 7, 2016
Last verified: January 2016
Quality control of IORT as a boost with 20 Gy followed by EBRT

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

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:

Further study details as provided by Universitätsmedizin Mannheim:

Primary Outcome Measures:
  • Local recurrence rate [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Toxicity, Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    LENT SOMA Scale for toxicity regular follow up

Estimated Enrollment: 1000
Study Start Date: September 2011
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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 = 1000 patients is planned.

Ages Eligible for Study:   18 Years to 85 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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 Blank, 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
  More Information


Responsible Party: Frederik Wenz, Prof. Dr. med. Frederik Wenz, Universitätsmedizin Mannheim Identifier: NCT01440010     History of Changes
Other Study ID Numbers: TARGIT BQR 
Study First Received: September 22, 2011
Last Updated: January 7, 2016
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases processed this record on May 04, 2016