Hypofractionated Versus Standard Fractionated Whole Breast Irradiation to Node-negative Breast Cancer Patients: a Randomized Phase III Trial, CIRRO (The Lundbeck Foundation Center for International Research in Radiation Oncology)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Danish Breast Cancer Cooperative Group
- Enrollment
- 976
- Locations
- 1
- Primary Endpoint
- Grade 2 or 3 fibrosis 3 years after radiotherapy
- Last Updated
- 4 years ago
Overview
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 conservation for early breast cancer.
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 morbidity; secondly, we want to investigate the frequency of local recurrences, and try to establish a genetic risk profile for development of late radiation morbidity. The hypothesis is that women operated with breast conserving strategy for early breast cancer can be offered moderately hypofractionated radiotherapy without developing more late radiation morbidity compared to standard fractionated radiotherapy.
Investigators
Birgitte Offersen
M.D., ph.d., associate professor
Danish Breast Cancer Cooperative Group
Eligibility Criteria
Inclusion Criteria
- •operated with breast conserving strategy for:
- •invasive breast cancer, pT1-2, pN0-1mi, M0 OR
- •carcinoma in situ of the breast
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Grade 2 or 3 fibrosis 3 years after radiotherapy
Time Frame: 3 years
Secondary Outcomes
- Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival(10 years)