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

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ClinicalTrials.gov Identifier: NCT01440010
Recruitment Status : Recruiting
First Posted : September 23, 2011
Last Update Posted : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. med. Elena Sperk, Universitätsmedizin Mannheim

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

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

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 1200 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)
Actual Study Start Date : September 1, 2011
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 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 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.
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

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 ClinicalTrials.gov identifier (NCT number): NCT01440010


Contacts
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Contact: Elena Sperk, MD +49 621 383 4142 elena.sperk@umm.de
Contact: Daniela Stuber, MD +49 621 383 6020 studien.strahlen@medma.uni-heidelberg.de

Locations
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Germany
University Medical Center Mannheim Recruiting
Mannheim, Germany, 68167
Contact: Elena Sperk, MD    +49 621 383 3530    elena.sperk@medma.uni-heidelberg.de   
Contact: Daniela Stuber    +49 621 383 3418    studien.strahlen@medma.uni-heidelberg.de   
Principal Investigator: Elena Sperk, MD         
Sponsors and Collaborators
Universitätsmedizin Mannheim
Investigators
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Principal Investigator: Elena Sperk, MD Universitätsmedizin Mannheim
Publications:

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Responsible Party: Dr. med. Elena Sperk, Senior Consultant, Head Clinical Trials Unit Department of Radiation Oncology, Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier: NCT01440010    
Other Study ID Numbers: TARGIT BQR
First Posted: September 23, 2011    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 2020
Keywords provided by Dr. med. Elena Sperk, Universitätsmedizin Mannheim:
IORT
Boost
Breast cancer
Local recurrence
Toxicity
LENT SOMA
TARGIT
Quality Control Registry
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases