Breast Cancer Clinical Trial
Official title:
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)
Verified date | August 2021 |
Source | Danish Breast Cancer Cooperative Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 976 |
Est. completion date | May 2024 |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 41 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | The Danish Breast Cancer Cooperative Group | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Danish Breast Cancer Cooperative Group | Danish Cancer Society |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Grade 2 or 3 fibrosis 3 years after radiotherapy | 3 years | ||
Secondary | Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival | 10 years |
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