This trial is active, not recruiting.

Conditions breast cancer, carcinoma in situ of the breast
Treatments standard fractionated radiotherapy, hypofractionated radiotherapy
Phase phase 2
Sponsor Danish Breast Cancer Cooperative Group
Collaborator Danish Cancer Society
Start date May 2009
End date May 2022
Trial size 976 participants
Trial identifier NCT00909818, CIRRO IP030209, DBCG hypo protocol, The Danish Cancer Society


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
50 Gy/25 fractions, 2.00 Gy/fraction, 5 fractions per week
standard fractionated radiotherapy
standard fractionated radiotherapy 50 Gy/25 fractions
hypofractionated radiotherapy 40 Gy/15 fractions
hypofractionated radiotherapy
hypofractionated radiotherapy 40 Gy/15 fractions

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
time frame: 10 years

Eligibility Criteria

Female participants at least 41 years old.

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

Additional Information

Official title 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)
Principal investigator Birgitte Offersen, MD, phd
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Danish Breast Cancer Cooperative Group.