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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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13 June 2022 |
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Main ID: |
NCT01299987 |
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Date of registration:
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18/02/2011 |
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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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Prospective Phase II Study of Intraoperative Radiotherapy (IORT) in Elderly Patients With Small Breast Cancer
TARGIT-E |
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Scientific title:
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TARGIT-E(Elderly) Prospective Phase II Study of Intraoperative Radiotherapy (IORT) in Elderly Patients With Small Breast Cancer |
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Date of first enrolment:
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January 2011 |
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Target sample size:
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541 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01299987 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Sperk Elena, 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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Medical Faculty Mannheim |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- cT1c cN0 cM0
- = 70 years old
- invasive-ductal histology
- compliance
- informed consent
Exclusion Criteria:
- extensive intraductal component (EIC)
- multifocality /-centricity
- lymph vessel invasion (L1)
- clinical signs of distant metastases or clinically suspicious lymph nodes
- other histology
- < 70 years old
- missing informed consent or non-compliance
- bilateral breast cancer at time of diagnosis
- known BRACA 1/2 mutations (genetic testing not required)
Age minimum:
70 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Neoplasms
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Neoplasm Recurrence, Local
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Neoplasms
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Breast Diseases
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Intervention(s)
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Radiation: intraoperative radiotherapy
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Primary Outcome(s)
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Local Relapse
[Time Frame: up to ten years]
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Secondary Outcome(s)
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General and breast-specific Quality of Life after IORT
[Time Frame: up to 10 years]
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Cosmesis
[Time Frame: up to 7.5 years]
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Overall Survival
[Time Frame: up to ten years]
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Ipsi- or Contralateral Breast Cancer
[Time Frame: up to ten years]
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Late toxicity after IORT
[Time Frame: up to ten 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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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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