Status:
UNKNOWN
Hypofractionated Versus Standard Fractionated Whole Breast Irradiation to Node-negative Breast Cancer Patients
Lead Sponsor:
Danish Breast Cancer Cooperative Group
Collaborating Sponsors:
Danish Cancer Society
Conditions:
Breast Cancer
Carcinoma in Situ of the Breast
Eligibility:
FEMALE
41+ years
Phase:
NA
Brief Summary
The purpose of this study is to investigate the difference in late radiation morbidity between hypofractionated and standard fractionated breast irradiation given to women operated with breast conserv...
Detailed Description
The randomization is between 50 Gy/25 fractions, 2.0 Gy per fraction, 5 fractions weekly, and 40 Gy/15 fractions, 2.67 Gy per fraction, 5 fractions weekly. The primary endpoint is late radiation morbi...
Eligibility Criteria
Inclusion
- operated with breast conserving strategy for:
- invasive breast cancer, pT1-2, pN0-1mi, M0 OR
- carcinoma in situ of the breast
Exclusion
- previous radiation of the breast/thorax
- breast implants
- pregnant/lactating
- comorbidity which may hinder the patient in completing the therapy and complete follow up for 10 years
Key Trial Info
Start Date :
May 14 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
976 Patients enrolled
Trial Details
Trial ID
NCT00909818
Start Date
May 14 2009
End Date
May 1 2024
Last Update
August 24 2021
Active Locations (1)
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1
The Danish Breast Cancer Cooperative Group
Copenhagen, Denmark, DK-2100 Ø