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Partial Breast Irradiation With Multi-Catheter Brachytherapy for pT1-2pN0 Breast Cancer After Breast Conserving Surgery

This study has been completed.
Sponsor:
Information provided by:
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT00392184
First received: October 24, 2006
Last updated: February 17, 2009
Last verified: February 2009

October 24, 2006
February 17, 2009
November 2000
February 2009   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00392184 on ClinicalTrials.gov Archive Site
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Partial Breast Irradiation With Multi-Catheter Brachytherapy for pT1-2pN0 Breast Cancer After Breast Conserving Surgery
Partial Breast Irradiation With Multi-Catheter Brachytherapy for pT1-2pN0 Breast Cancer After Breast Conserving Surgery

The purpose of this study is to determine whether accelerated partial breast irradiation (APBI) with multi-catheter brachytherapy is safe and effective.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
Procedure: Accelerated partial breast irradiation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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October 2010
February 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • pT1/2 (≤ 3 cm)
  • pN0 or pN1 mi
  • M0 and no contralateral BC
  • Clear margins (≥ 2 mm)
  • Age ≥ 35 years
  • ER and/or PR positive

Exclusion Criteria:

  • Multifocality or Multicentricity
  • EIC
  • Lymphovascular invasion
  • Poorly differentiated tumors
  • Diffuse microcalcifications
Female
35 Years to 80 Years
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Contact information is only displayed when the study is recruiting subjects
Austria,   Germany
 
NCT00392184
German-Austrian APBI Trial
No
Oliver Ott, MD, University Hospital Erlangen
University of Erlangen-Nürnberg
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Study Chair: Vratislav Strnad, MD University Hospital Erlangen, Germany
Study Director: Oliver J Ott, MD University Hospital Erlangen, Germany
Principal Investigator: Guido Hildebrandt, MD University Hospital Leipzig, Germany
Principal Investigator: Richard Pötter, MD University Hospital AKH Vienna, Austria
Principal Investigator: Joe Hammer, MD Hospital Barmherzige Schwestern Linz, Austria
University of Erlangen-Nürnberg Medical School
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP