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

History of Changes

Purpose

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

Condition	Intervention	Phase
Breast Cancer	Procedure: Accelerated partial breast irradiation	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Partial Breast Irradiation With Multi-Catheter Brachytherapy for pT1-2pN0 Breast Cancer After Breast Conserving Surgery

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by University of Erlangen-Nürnberg Medical School:

Study Start Date:	November 2000
Estimated Study Completion Date:	October 2010
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	35 Years to 80 Years
Genders Eligible for Study:	Female

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00392184

Locations

Austria
Hospital Barmherzige Schwestern Linz
Linz, Austria
University Hospital AKH Vienna
Vienna, Austria, 1090
Germany
University Hospital Erlangen
Erlangen, Germany, 91052
University Hospital Leipzig
Leipzig, Germany, 04103

Sponsors and Collaborators

University of Erlangen-Nürnberg

Investigators

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

More Information

Publications:

Ott OJ, Potter R, Hammer J, Hildebrandt G, Lotter M, Resch A, Pohls U, Beckmann MW, Sauer R, Strnad V. Accelerated partial breast irradiation with iridium-192 multicatheter PDR/HDR brachytherapy. Preliminary results of the German-Austrian multicenter trial. Strahlenther Onkol. 2004 Oct;180(10):642-9.

Strnad V, Ott O, Potter R, Hildebrandt G, Hammer J, Resch A, Lotter M, Ackermann S, Beckmann MW, Sauer R. Interstitial brachytherapy alone after breast conserving surgery: interim results of a German-Austrian multicenter phase II trial. Brachytherapy. 2004;3(3):115-9.

Ott OJ, Potter R, Hildebrandt G, Hammer J, Lotter M, Beckmann MW, Sauer R, Strnad V. [Partial breast irradiation for early breast cancer with favorable prognostic factors: 3-year results of the German-Austrian phase II-trial] Rofo. 2005 Jul;177(7):962-7. German.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ott OJ, Hildebrandt G, Pötter R, Hammer J, Hindemith M, Resch A, Spiegl K, Lotter M, Uter W, Kortmann RD, Schrauder M, Beckmann MW, Fietkau R, Strnad V. Accelerated partial breast irradiation with interstitial implants: risk factors associated with increased local recurrence. Int J Radiat Oncol Biol Phys. 2011 Aug 1;80(5):1458-63. Epub 2010 Aug 2.

Responsible Party:	Oliver Ott, MD, University Hospital Erlangen
ClinicalTrials.gov Identifier:	NCT00392184 History of Changes
Other Study ID Numbers:	German-Austrian APBI Trial
Study First Received:	October 24, 2006
Last Updated:	February 17, 2009
Health Authority:	Germany: Ethics Commission

Keywords provided by University of Erlangen-Nürnberg Medical School:

accelerated partial breast irradiation
multicatheter brachytherapy
high dose rate brachytherapy
pulsed dose rate brachytherapy

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013

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