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APBI Versus EBRT Therapy After Breast Conserving Surgery for Low-risk Breast Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
University of Erlangen-Nürnberg Medical School
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT00402519
First received: November 21, 2006
Last updated: May 12, 2016
Last verified: May 2016
| Tracking Information | ||||||||||
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| First Received Date ICMJE | November 21, 2006 | |||||||||
| Last Updated Date | May 12, 2016 | |||||||||
| Start Date ICMJE | November 2004 | |||||||||
| Primary Completion Date | November 2009 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
Local control [ Time Frame: 5-years, 10 ten-years ] | |||||||||
| Original Primary Outcome Measures ICMJE |
Local control | |||||||||
| Change History | Complete list of historical versions of study NCT00402519 on ClinicalTrials.gov Archive Site | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | |||||||||
| Original Other Outcome Measures ICMJE | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | APBI Versus EBRT Therapy After Breast Conserving Surgery for Low-risk Breast Cancer | |||||||||
| Official Title ICMJE | 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 | |||||||||
| Brief Summary | 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. | |||||||||
| Detailed Description | 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. | |||||||||
| Study Type ICMJE | Interventional | |||||||||
| Study Phase | Phase 3 | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Breast Cancer | |||||||||
| Intervention ICMJE |
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| Study Arms |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Active, not recruiting | |||||||||
| Enrollment ICMJE | 1300 | |||||||||
| Estimated Completion Date | November 2019 | |||||||||
| Primary Completion Date | November 2009 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 40 Years and older (Adult, Senior) | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | Austria, Germany, Hungary, Poland, Spain | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT00402519 | |||||||||
| Other Study ID Numbers ICMJE | GEC-ESTRO APBI Trial | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement |
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| Responsible Party | University of Erlangen-Nürnberg Medical School | |||||||||
| Study Sponsor ICMJE | University of Erlangen-Nürnberg Medical School | |||||||||
| Collaborators ICMJE | Not Provided | |||||||||
| Investigators ICMJE |
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| PRS Account | University of Erlangen-Nürnberg Medical School | |||||||||
| Verification Date | May 2016 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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