Spots Global Cancer Trial Database for Hypofractionated Versus Standard Fractionated Whole Breast Irradiation to Node-negative Breast Cancer Patients
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Trial Identification
Brief Title: Hypofractionated Versus Standard Fractionated Whole Breast Irradiation to Node-negative Breast Cancer Patients
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)
Study ID: NCT00909818
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 41 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
The Danish Breast Cancer Cooperative Group, Copenhagen, , Denmark
Contact Details
Name: Lars Stenbygaard, MD
Affiliation: Aalborg University Hospital
Role: STUDY_CHAIR
Name: Birgitte Offersen, MD, Ph.D
Affiliation: Aarhus University Hospital
Role: STUDY_CHAIR
Name: Erik Jakobsen, MD
Affiliation: Vejle Hospital
Role: STUDY_CHAIR
Name: Mette H Nielsen, MD, phd
Affiliation: Odense University Hospital
Role: STUDY_CHAIR
Name: Birgitte Offersen, MD, phd
Affiliation: Aarhus University Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Mechthild Krause, M.D., Prof
Affiliation: University Clinic Carl Gustav Carus Dresden
Role: STUDY_CHAIR
Name: Andreas Schreiber, M.D., Ph.D.
Affiliation: Praxis für Strahlentherapie am Klinikum Dresden-Friedrichstadt
Role: STUDY_CHAIR
Name: Ingvil Mjaaland, M.D.
Affiliation: Helse Stavanger HF, Sorlandet Sykehus HF
Role: STUDY_CHAIR
Name: Unn-Miriam Kasti, M.D.
Affiliation: Kristiansand Sykehus
Role: STUDY_CHAIR
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