Status:
RECRUITING
HYPofractionated Adjuvant RadioTherapy in 1 Versus 2 Weeks in High-risk Patients With Breast Cancer (HYPART).
Lead Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions:
Breast Cancer
Hypofractionation
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
We at PGIMER have been practicing hypofractionated radiotherapy in breast cancer patients for the last 4 decades. Our standard doses have been 35Gy/15#/3wks to the chest wall after mastectomy and 40Gy...
Detailed Description
Aim: To test a 1-week schedule of hypofractionated adjuvant whole breast/chest wall and/or regional nodal radiotherapy against 2 weeks for loco-regional control, acute and late toxicities, quality of ...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Female or male
- Invasive carcinoma of the breast
- Breast conserving surgery(BCS) with axillary clearance or total mastectomy with axillary clearance(TMAC); (reconstruction allowed but not with implant; tissue expanders with distant metal ports are allowed)
- Concurrent trastuzumab and hormone therapy is allowed
- Axillary staging and/or dissection
- Complete microscopic excision of primary tumour
- pT3-4pN2-3 M0 disease
- Clinical stage III disease or pathological node positive if they have received neo-adjuvant chemotherapy.
- Written informed consent
- Able to comply with follow-up
Exclusion
- Supraclavicular node or internal mammary node or distant metastasis
- 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
- Pregnancy
- Concurrent cytotoxic chemotherapy(sequential neoadjuvant or adjuvant cytotoxic therapy allowed)
Key Trial Info
Start Date :
March 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 20 2028
Estimated Enrollment :
1018 Patients enrolled
Trial Details
Trial ID
NCT04472845
Start Date
March 30 2021
End Date
August 20 2028
Last Update
December 8 2022
Active Locations (1)
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1
Budhi Singh Yadav
Chandigarh, India, 160012