Status:
COMPLETED
Hypofractionated Radiation Therapy in Patients With Breast Cancer
Lead Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions:
Breast Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The investigators at PGIMER have been practicing hypofractionation radiotherapy with a dose of 35Gy/15#/3wks to the chest wall in post mastectomy and 40Gy/16#/3wks in breast conservation in breast can...
Detailed Description
Patients to be included in this study will be pre-operatively staged according to American Joint Committee on Cancer (AJCC) 7th edition, International Union against cancer ( which uses TNM staging ) a...
Eligibility Criteria
Inclusion
- Invasive carcinoma of the breast
- Breast conservation surgery or mastectomy
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
June 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
1070 Patients enrolled
Trial Details
Trial ID
NCT04075058
Start Date
June 1 2015
End Date
December 1 2020
Last Update
June 23 2021
Active Locations (1)
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1
Dr Budhi Singh Yadav
Chandigarh, N/A = Not Applicable, India, 91 160012