Status:
COMPLETED
Safety of Ultra-hypofractionated Whole Breast Irradiation After Breast-conserving Surgery
Lead Sponsor:
Azienda Ospedaliero-Universitaria Careggi
Conditions:
Breast Cancer
Radiotherapy Side Effect
Eligibility:
FEMALE
18-99 years
Brief Summary
SAFE-FORWARD is an observational prospective cohort study. Patient population included both invasive and ductal carcinoma in situ (DCIS) breast cancer receiving ultra-hypofractionated whole breast irr...
Detailed Description
This prospective cohort study aims to assess heart toxicity and safety using a 1-week radiation schedule regimen of 26 Gy in five daily fractions. The primary endpoint was defined as detection of any...
Eligibility Criteria
Inclusion
- Invasive and ductal carcinoma in situ (DCIS) breast cancer
- Indication to ultra-hypofractionated whole breast irradiation
- Written informed consent
- Aged more than 18 years old
Exclusion
- Neoadjuvant and adjuvant chemotherapy
- Tumor bed radiation boost prescription
Key Trial Info
Start Date :
November 30 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 8 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04842409
Start Date
November 30 2021
End Date
December 8 2022
Last Update
July 20 2023
Active Locations (1)
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1
Azienda Ospedaliero-Universitaria Careggi, Florence University
Florence, Italy, 50134