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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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29 June 2015 |
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Main ID: |
NCT02460744 |
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Date of registration:
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26/05/2015 |
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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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2-weeks of Adjuvant Radiotherapy in Patients With Breast Cancer
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Scientific title:
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A Phase II Study of 2-weeks of Adjuvant Whole Breast/Chest Wall and/or Regional Nodal Radiotherapy in Patients With Breast Cancer |
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Date of first enrolment:
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June 2013 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02460744 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety 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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India
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Contacts
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Name:
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Budhi S Yadav, 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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PGIMER, Chandigarh, India |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- invasive carcinoma of the breast
- breast conservation surgery or mastectomy (reconstruction allowed but not with
implant. Tissue expanders with distant metal ports are allowed)
- axillary staging &/or dissection
- complete microscopic excision of primary tumour
- pT1-3 pN0-2 M0 disease
- written informed consent
- able to comply with follow up N.B. Concurrent trastuzumab and hormone therapy is
allowed
Exclusion Criteria:
- past history of malignancy except (i) basal cell skin cancer and CIN cervix uteri or
(ii) non-breast malignancy allowed if treated with curative intent and at least 5
years disease free
- contralateral breast cancer, including DCIS, irrespective of date of diagnosis
- breast reconstruction using implants
- concurrent cytotoxic chemotherapy (sequential neoadjuvant or adjuvant cytotoxic
therapy allowed)
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Both
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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: Hypofractionation
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Primary Outcome(s)
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acute skin and subcutaneous toxicity assessed using a RTOG grading system
[Time Frame: 1 month]
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Secondary Outcome(s)
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Cosmetic score analysis using Harvard/NSABP/RTOG Breast Cosmesis Grading Scale
[Time Frame: Base line, one month and 6 months after completion of radiation]
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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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