Hypofractionated Versus Standard Fractionated Whole Breast Irradiation to Node-negative Breast Cancer Patients
NCT ID: NCT00909818
Last Updated: 2021-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
976 participants
INTERVENTIONAL
2009-05-14
2024-05-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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standard fractionated radiotherapy
50 Gy/25 fractions, 2.00 Gy/fraction, 5 fractions per week
standard fractionated radiotherapy
standard fractionated radiotherapy 50 Gy/25 fractions
hypofractionated radiotherapy
hypofractionated radiotherapy 40 Gy/15 fractions
hypofractionated radiotherapy
hypofractionated radiotherapy 40 Gy/15 fractions
Interventions
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standard fractionated radiotherapy
standard fractionated radiotherapy 50 Gy/25 fractions
hypofractionated radiotherapy
hypofractionated radiotherapy 40 Gy/15 fractions
Eligibility Criteria
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Inclusion Criteria
1. invasive breast cancer, pT1-2, pN0-1mi, M0 OR
2. carcinoma in situ of the breast
Exclusion Criteria
* breast implants
* pregnant/lactating
* comorbidity which may hinder the patient in completing the therapy and complete follow up for 10 years
41 Years
FEMALE
No
Sponsors
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Danish Cancer Society
OTHER
Danish Breast Cancer Cooperative Group
OTHER
Responsible Party
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Birgitte Offersen
M.D., ph.d., associate professor
Principal Investigators
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Lars Stenbygaard, MD
Role: STUDY_CHAIR
Aalborg University Hospital
Birgitte Offersen, MD, Ph.D
Role: STUDY_CHAIR
Aarhus University Hospital
Erik Jakobsen, MD
Role: STUDY_CHAIR
Vejle Hospital
Mette H Nielsen, MD, phd
Role: STUDY_CHAIR
Odense University Hospital
Birgitte Offersen, MD, phd
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Mechthild Krause, M.D., Prof
Role: STUDY_CHAIR
University Clinic Carl Gustav Carus Dresden
Andreas Schreiber, M.D., Ph.D.
Role: STUDY_CHAIR
Praxis für Strahlentherapie am Klinikum Dresden-Friedrichstadt
Ingvil Mjaaland, M.D.
Role: STUDY_CHAIR
Helse Stavanger HF, Sorlandet Sykehus HF
Unn-Miriam Kasti, M.D.
Role: STUDY_CHAIR
Kristiansand Sykehus
Locations
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The Danish Breast Cancer Cooperative Group
Copenhagen, , Denmark
Countries
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References
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Offersen BV, Alsner J, Nielsen HM, Jakobsen EH, Nielsen MH, Krause M, Stenbygaard L, Mjaaland I, Schreiber A, Kasti UM, Overgaard J; Danish Breast Cancer Group Radiation Therapy Committee. Hypofractionated Versus Standard Fractionated Radiotherapy in Patients With Early Breast Cancer or Ductal Carcinoma In Situ in a Randomized Phase III Trial: The DBCG HYPO Trial. J Clin Oncol. 2020 Nov 1;38(31):3615-3625. doi: 10.1200/JCO.20.01363. Epub 2020 Sep 10.
Other Identifiers
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CIRRO IP030209
Identifier Type: -
Identifier Source: secondary_id
The Danish Cancer Society
Identifier Type: -
Identifier Source: secondary_id
DBCG hypo protocol
Identifier Type: -
Identifier Source: org_study_id
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