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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Danish Cancer Society
Information provided by (Responsible Party):
Birgitte Offersen, Danish Breast Cancer Cooperative Group
ClinicalTrials.gov Identifier:
NCT00909818
First received: May 28, 2009
Last updated: April 9, 2014
Last verified: April 2014

May 28, 2009
April 9, 2014
May 2009
May 2022   (final data collection date for primary outcome measure)
Grade 2 or 3 fibrosis 3 years after radiotherapy [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00909818 on ClinicalTrials.gov Archive Site
Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Hypofractionated Versus Standard Fractionated Whole Breast Irradiation to Node-negative Breast Cancer Patients
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)

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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Breast Cancer
  • Carcinoma in Situ of the Breast
  • Radiation: standard fractionated radiotherapy
    standard fractionated radiotherapy 50 Gy/25 fractions
  • Radiation: hypofractionated radiotherapy
    hypofractionated radiotherapy 40 Gy/15 fractions
  • Active Comparator: standard fractionated radiotherapy
    50 Gy/25 fractions, 2.00 Gy/fraction, 5 fractions per week
    Intervention: Radiation: standard fractionated radiotherapy
  • Experimental: hypofractionated radiotherapy
    hypofractionated radiotherapy 40 Gy/15 fractions
    Intervention: Radiation: hypofractionated radiotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
976
May 2022
May 2022   (final data collection date for primary outcome measure)

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
Female
41 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00909818
DBCG hypo protocol, CIRRO IP030209, The Danish Cancer Society
Yes
Birgitte Offersen, Danish Breast Cancer Cooperative Group
Danish Breast Cancer Cooperative Group
Danish Cancer Society
Study Chair: Lars Stenbygaard, MD Aalborg Universitetshospital
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
Danish Breast Cancer Cooperative Group
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP