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 October 2013 by Universitätsmedizin Mannheim
Sponsor:
Information provided by (Responsible Party):
Frederik Wenz, University Hospital Mannheim
ClinicalTrials.gov Identifier:
NCT01440010
First received: September 22, 2011
Last updated: October 8, 2013
Last verified: October 2013
  Purpose

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.


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
Groups/Cohorts Assigned Interventions
IORT Boost
Boost with 20 Gy during BCS, EBRT with 46-50 Gy
Radiation: IORT with 50 kV x-rays, 20 Gy
see above

  Eligibility

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).

Criteria

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 ClinicalTrials.gov identifier: NCT01440010

Contacts
Contact: Frederik Wenz, MD +49 621 383 4960 frederik.wenz@umm.de
Contact: Elena Sperk, MD +49 621 383 3530 elena.sperk@medma.uni-heidelberg.de

Locations
Germany
University Medical Center Mannheim Recruiting
Mannheim, Germany, 68167
Contact: Elena Blank, MD    +49 621 383 3530    elena.blank@umm.de   
Contact: Anke Keller, MSc    +49 621 383 4493    anke.keller@umm.de   
Principal Investigator: Frederik Wenz, Prof. Dr.med.         
Sub-Investigator: Elena Blank, Dr.med.         
Sponsors and Collaborators
Universitätsmedizin Mannheim
Investigators
Principal Investigator: Frederik Wenz, MD Universitätsmedizin Mannheim
  More Information

Publications:

Responsible Party: Frederik Wenz, Prof. Dr. med. Frederik Wenz, University Hospital Mannheim
ClinicalTrials.gov Identifier: NCT01440010     History of Changes
Other Study ID Numbers: TARGIT BQR
Study First Received: September 22, 2011
Last Updated: October 8, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Universitätsmedizin Mannheim:
IORT
Boost
Breast cancer
Local recurrence
Toxicity
LENT SOMA
TARGIT
Quality Control Registry

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

ClinicalTrials.gov processed this record on September 18, 2014