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

Tracking Information

First Received Date ^ICMJE

October 24, 2006

Last Updated Date

February 17, 2009

Start Date ^ICMJE

November 2000

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00392184 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Procedure: Accelerated partial breast irradiation

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

October 2010

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

35 Years to 80 Years

Accepts Healthy Volunteers

Not Provided

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria, Germany

Administrative Information

NCT Number ^ICMJE

NCT00392184

Other Study ID Numbers ^ICMJE

German-Austrian APBI Trial

Has Data Monitoring Committee

Responsible Party

Oliver Ott, MD, University Hospital Erlangen

Study Sponsor ^ICMJE

University of Erlangen-Nürnberg

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

University of Erlangen-Nürnberg Medical School

Verification Date

February 2009

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

To Top