NCT00909818

Hypofractionated Versus Standard Fractionated Whole Breast Irradiation to Node-negative Breast Cancer Patients

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)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 976 (estimated)
• Sponsor: Danish Breast Cancer Cooperative Group · Academic / Other
• Sex: Female
• Age: 41 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Carcinoma in Situ of the Breast

Interventions

Type	Name	Description
RADIATION	standard fractionated radiotherapy	standard fractionated radiotherapy 50 Gy/25 fractions
RADIATION	hypofractionated radiotherapy	hypofractionated radiotherapy 40 Gy/15 fractions

Timeline

• Start date: 2009-05-14
• Primary completion: 2024-05-01
• Completion: 2024-05-01
• First posted: 2009-05-29
• Last updated: 2021-08-24

Locations

1 site across 1 country: Denmark