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Hypofractionated Versus Standard Fractionated Whole Breast Irradiation to Node-negative Breast Cancer Patients

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ClinicalTrials.gov Identifier: NCT00909818
Recruitment Status : Unknown
Verified August 2021 by Birgitte Offersen, Danish Breast Cancer Cooperative Group.
Recruitment status was:  Active, not recruiting
First Posted : May 29, 2009
Last Update Posted : August 24, 2021
Sponsor:
Collaborator:
Danish Cancer Society
Information provided by (Responsible Party):
Birgitte Offersen, Danish Breast Cancer Cooperative Group

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Carcinoma in Situ of the Breast Radiation: standard fractionated radiotherapy Radiation: hypofractionated radiotherapy Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 976 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : May 14, 2009
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: standard fractionated radiotherapy
50 Gy/25 fractions, 2.00 Gy/fraction, 5 fractions per week
 Radiation: standard fractionated radiotherapy
standard fractionated radiotherapy 50 Gy/25 fractions
Experimental: hypofractionated radiotherapy
hypofractionated radiotherapy 40 Gy/15 fractions
 Radiation: hypofractionated radiotherapy
hypofractionated radiotherapy 40 Gy/15 fractions


Outcome Measures
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Primary Outcome Measures :
  1. Grade 2 or 3 fibrosis 3 years after radiotherapy [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival [ Time Frame: 10 years ]

Eligibility Criteria
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Ages Eligible for Study:   41 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00909818


Locations
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Denmark
The Danish Breast Cancer Cooperative Group
Copenhagen, Denmark, DK-2100 Ø
Sponsors and Collaborators
Danish Breast Cancer Cooperative Group
Danish Cancer Society
Investigators
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Study Chair: Lars Stenbygaard, MD Aalborg University Hospital
Study Chair: Birgitte Offersen, MD, Ph.D Aarhus University Hospital
Study Chair: Erik Jakobsen, MD Vejle Hospital
Study Chair: Mette H Nielsen, MD, phd Odense University Hospital
Principal Investigator: Birgitte Offersen, MD, phd Aarhus University Hospital
Study Chair: Mechthild Krause, M.D., Prof University Clinic Carl Gustav Carus Dresden
Study Chair: Andreas Schreiber, M.D., Ph.D. Praxis für Strahlentherapie am Klinikum Dresden-Friedrichstadt
Study Chair: Ingvil Mjaaland, M.D. Helse Stavanger HF, Sorlandet Sykehus HF
Study Chair: Unn-Miriam Kasti, M.D. Kristiansand Sykehus
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Birgitte Offersen, M.D., ph.d., associate professor, Danish Breast Cancer Cooperative Group
ClinicalTrials.gov Identifier: NCT00909818    
Other Study ID Numbers: DBCG hypo protocol
CIRRO IP030209
The Danish Cancer Society
First Posted: May 29, 2009    Key Record Dates
Last Update Posted: August 24, 2021
Last Verified: August 2021
Additional relevant MeSH terms:
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Breast Neoplasms
Carcinoma in Situ
Breast Carcinoma In Situ
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type