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Main
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Note: This record shows only 22 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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19 February 2015 |
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Main ID: |
NCT00499057 |
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Date of registration:
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09/07/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Partial Breast Irradiation With Interstitial High Dose Rate Brachytherapy
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Scientific title:
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Interstitial High Dose-Rate Brachytherapy for Partial Breast Irradiation in Early Breast Cancer: Results of Phase II Prospective Study |
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Date of first enrolment:
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August 2003 |
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Target sample size:
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150 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00499057 |
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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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Phase:
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Phase 2
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Countries of recruitment
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Italy
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Contacts
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Name:
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Cynthia Aristei, Prof. M.D. |
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Address:
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Telephone:
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00390755784306 |
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Email:
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cynthia.aristei@unipg.it |
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Affiliation:
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Name:
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Cynthia Aristei, Prof. M.D. |
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Address:
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Telephone:
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00390755784306 |
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Email:
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cynthia.aristei@unipg.it |
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Affiliation:
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Name:
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Cynthia Aristei, Prof. M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Perugia, Italy |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age > or = 40 years
- ECOG performance status 0-2
- T dimensions = 2.5 cm
- Negative surgical margins
- Negative axillary lymph nodes
- Suitable breast anatomy for implantation
Exclusion Criteria:
- Age < 40 years
- ECOG performance status > 2
- T dimensions > 2.5
- Positive surgical margins
- Positive axillary lymph node
- Infiltrating lobular histology
- Significant areas of lobular carcinoma in situ
- Paget's disease of the nipple
- Extensive intraductal component (EIC)
- Lymphovascular invasion
- Multifocality (n) skin infiltration
Age minimum:
40 Years
Age maximum:
85 Years
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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Radiation: interstitial high dose-rate brachytherapy, PBI
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Primary Outcome(s)
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local relapses
[Time Frame: 6 months]
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cancer related deaths
[Time Frame: 6 months]
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Secondary Outcome(s)
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quality of life
[Time Frame: 6 months]
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toxicity
[Time Frame: 6 months]
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cosmetic results
[Time Frame: 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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