Hypofractionated Versus Standard Fractionated Whole Breast Irradiation to Node-negative Breast Cancer Patients
This trial is active, not recruiting.
|Conditions||breast cancer, carcinoma in situ of the breast|
|Treatments||standard fractionated radiotherapy, hypofractionated radiotherapy|
|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.
|Intervention model||parallel assignment|
Grade 2 or 3 fibrosis 3 years after radiotherapy
time frame: 3 years
Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival
time frame: 10 years
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
|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.|
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