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
  Purpose

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 Intervention Phase
Breast Cancer
Carcinoma in Situ of the Breast
Radiation: standard fractionated radiotherapy
Radiation: hypofractionated radiotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Danish Breast Cancer Cooperative Group:

Primary Outcome Measures:
  • Grade 2 or 3 fibrosis 3 years after radiotherapy [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 976
Study Start Date: May 2009
Estimated Study Completion Date: May 2022
Estimated Primary Completion Date: May 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   41 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00909818

Locations
Denmark
The Danish Breast Cancer Cooperative Group
Copenhagen, Denmark, DK-2100 Ø
Sponsors and Collaborators
Danish Breast Cancer Cooperative Group
Danish Cancer Society
Investigators
Study Chair: Lars Stenbygaard, MD Aalborg Universityhospital
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

No publications provided

Responsible Party: Birgitte Offersen, M.D., ph.d., associate professor, Danish Breast Cancer Cooperative Group
ClinicalTrials.gov Identifier: NCT00909818     History of Changes
Other Study ID Numbers: DBCG hypo protocol, CIRRO IP030209, The Danish Cancer Society
Study First Received: May 28, 2009
Last Updated: April 9, 2014
Health Authority: Denmark: Ethics Committee

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Carcinoma in Situ
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on April 14, 2014