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| Sponsored by: |
University of Erlangen-Nürnberg |
| Information provided by: | University of Erlangen-Nürnberg |
| ClinicalTrials.gov Identifier: | NCT00402519 |
Purpose
To assess the role of interstitial brachytherapy alone compared to whole breast irradiation in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning local failure (all ipsilateral local recurrences) to affirm the hypothesis that local control rates in each arm are equivalent.
| Condition | Intervention | Phase |
|
Breast Cancer |
Procedure: Accelerated partial breast irradiation Procedure: External beam whole breast irradiation |
Phase III |
| Genetics Home Reference related topics: | breast cancer |
| MedlinePlus related topics: | Breast Cancer Cancer |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Interstitial Brachytherapy Alone Versus External Beam Radiation Therapy After Breast Conserving Surgery for Low-Risk Invasive Carcinoma and Low-Risk Ductal Carcinoma in Situ (DCIS) of the Female Breast |
| Estimated Enrollment: | 1170 |
| Study Start Date: | November 2004 |
Eligibility
| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Oliver J Ott, MD | +49 9131 8532935 | oliver.ott@strahlen.imed.uni-erlangen.de |
| Austria | |||||
| University Hospital AKH Wien, Department of Radiotherapy and Radiobiology | Recruiting | ||||
| Vienna, Austria | |||||
| Contact: Richard Pötter, MD Richard.Poetter@akhwien.at | |||||
| Principal Investigator: Richard Pötter, MD | |||||
| Sub-Investigator: Daniela Kauer-Dorner, MD | |||||
| Germany | |||||
| University Hospital Erlangen, Department of Radiation Oncology | Recruiting | ||||
| Erlangen, Germany, 91054 | |||||
| Contact: Oliver J Ott, MD +49 9131 8532935 oliver.ott@strahlen.imed.uni-erlangen.de | |||||
| Principal Investigator: Vratislav Strnad, MD | |||||
| Principal Investigator: Oliver J Ott, MD | |||||
| University Hospital Kiel, Department of Radiation Oncology | Recruiting | ||||
| Kiel, Germany | |||||
| Contact: Peter Niehoff, MD niehoff@onco.uni-kiel.de | |||||
| Principal Investigator: Peter Niehoff, MD | |||||
| University Hospital Leipzig, Department of Radiation Oncology | Recruiting | ||||
| Leipzig, Germany | |||||
| Contact: Guido Hildebrandt, MD hilg@medizin.uni-leipzig.de | |||||
| Principal Investigator: Guido Hildebrandt, MD | |||||
| University Hospital Lübeck, Department of Radiation Oncology | Recruiting | ||||
| Lübeck, Germany | |||||
| Contact: Gyoergy Kovacs, MD gyoergy.kovacs@uk-sh.de | |||||
| Principal Investigator: Gyoergy Kovacs, MD | |||||
| Hospital Barmherzige Brüder, Department of Radiation Oncology | Recruiting | ||||
| Regensburg, Germany | |||||
| Contact: Michael Allgäuer, MD michael.allgaeuer@barmherzige-regensburg.de | |||||
| Principal Investigator: Michael Allgäuer, MD | |||||
| Sub-Investigator: Michael Gessl, MD | |||||
| University Hospital Rostock, Department of Radiation Oncology | Recruiting | ||||
| Rostock, Germany | |||||
| Contact: Rainer Fietkau, MD rainer.fietkau@med.uni-rostock.de | |||||
| Principal Investigator: Rainer Fietkau, MD | |||||
| Sub-Investigator: Hellen Knauerhase, MD | |||||
| Hungary | |||||
| National Institute of Oncology, Department of Radiation Oncology | Recruiting | ||||
| Budapest, Hungary | |||||
| Contact: Csaba Polgár, MD polgar@oncol.hu | |||||
| Principal Investigator: Csaba Polgar, MD | |||||
| Sub-Investigator: Tibor Major, PhD | |||||
| Poland | |||||
| Kierownik Zakladu Brachyterapii, Cetrum Onkologii | Recruiting | ||||
| Warszawa, Poland | |||||
| Contact: Jaroslaw Lyczek, MD jaroslawlyczek@wp.pl | |||||
| Principal Investigator: Jaroslaw Lyczek, MD | |||||
| Spain | |||||
| Catalan Institut of Oncology, Department of Radiation Oncology | Recruiting | ||||
| Barcelona, Spain, 08907 | |||||
| Contact: Ferran Guedea, MD guedea@ico.scs.es | |||||
| Principal Investigator: Ferran Guedea, MD | |||||
| Sub-Investigator: Alfredo Polo, MD | |||||
| Valencian Institut of Oncology, Department of Radiation Oncology | Recruiting | ||||
| Valencia, Spain, 46009 | |||||
| Contact: Jose Luis Guinot, MD jlguinot@comv.es | |||||
| Principal Investigator: Jose Luis Guinot, MD | |||||
| Sub-Investigator: L. Arribas, MD | |||||
| University of Erlangen-Nürnberg |
| Study Chair: | Vratislav Strnad, MD | University Hospital Erlangen, Germany |
| Study Chair: | Csaba Polgár, MD | National Institute of Oncology Budapest, Hungary |
| Study Director: | Oliver J Ott, MD | University Hospital Erlangen, Germany |
More Information
Trial Homepage with a short version of the protocol 
  |
| Study ID Numbers: | GEC-ESTRO APBI Trial |
| First Received: | November 21, 2006 |
| Last Updated: | November 21, 2006 |
| ClinicalTrials.gov Identifier: | NCT00402519 |
| Health Authority: | Germany: Ethics Commission |
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