Hypofractionated Versus Standard Fractionated Whole Breast Irradiation to Node-negative Breast Cancer Patients: a Randomized Phase II Trial, CIRRO (The Lundbeck Foundation Center for International Research in Radiation Oncology)
41 Years
N/A
Female
Breast Cancer, Carcinoma in Situ of the Breast
Trial Information
Hypofractionated Versus Standard Fractionated Whole Breast Irradiation to Node-negative Breast Cancer Patients: a Randomized Phase II Trial, CIRRO (The Lundbeck Foundation Center for International Research in Radiation Oncology)
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.
Inclusion Criteria:
- operated with breast conserving strategy for:
1. invasive breast cancer, pT1-2, pN0-1mi, M0 OR
2. 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Grade 2 or 3 fibrosis 3 years after radiotherapy
Outcome Time Frame:
3 years
Safety Issue:
Yes
Principal Investigator
Lars Stenbygaard, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Aalborg Universityhospital
Authority:
Denmark: Ethics Committee
Study ID:
DBCG hypo protocol
NCT ID:
NCT00909818
Start Date:
May 2009
Completion Date:
May 2022
Related Keywords:
- Breast Cancer
- Carcinoma in Situ of the Breast
- Breast Neoplasms
- Carcinoma
- Carcinoma in Situ
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