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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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14 January 2013 |
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Main ID: |
NCT01072838 |
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Date of registration:
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18/02/2010 |
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Primary sponsor: |
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Public title:
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Safety Study for Short-course Accelerated, Hypofractionated Partial Breast Radiotherapy (APBI) in Women With Early Stage Breast Cancer Using the Contura MLB
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Scientific title:
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Safety and Feasibility of Short-Course, Accelerated, Hypofractionated Partial Breast Radiotherapy in Women With Early Stage Breast Cancer Using the Contura MLB Breast Brachytherapy Catheter: A Phase II Trial |
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Date of first enrolment:
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December 2009 |
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Target sample size:
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90 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01072838 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Natasha Behrmann |
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Address:
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Telephone:
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949-362-4800 |
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Email:
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Natasha.Behrmann@crbard.com |
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Affiliation:
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Name:
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Atif Khan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cancer Institute of New Jersey |
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Name:
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Douglas W. Arthur, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Virginia Commonwealth University |
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Name:
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Mihai Ghilezan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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William Beaumont Hospitals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Life expectancy > 10 years
- Lumpectomy with clear margins (negative per NSABP criteria)
- DCIS and/or invasive carcinoma
- If invasive, nodes must be negative
- T stage is Tis, T1 or T2<=3 cm max diameter
- ER(+) or ER(-)/PR(+)
Exclusion Criteria:
- Pregnant or breast feeding
- Active collagen-vascular disease
- Paget's disease of the breast
- Prior history of breast cancer
- Prior breast or thoracic radiotherapy
- Multicentric carcinoma
- Synchronous bilateral breast cancer
- Surgical margins that cannot be assessed or that are positive
- T Stage is T2>3 cm or greater
- ER(-)/PR(-)
Age minimum:
50 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Intervention(s)
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Device: Contura MLB Breast Brachytherapy Catheter
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Radiation: APBI (Dose Escalation)
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Primary Outcome(s)
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Delivery of short-course APBI will result in locoregional disease control that is equal to that reported for conventional fractionation schemes for APBI.
[Time Frame: 5 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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