Clinical trial NCT00909818: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Carcinoma in Situ of the Breast
Lead sponsor: Danish Breast Cancer Cooperative Group
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
First posted: 2009-05-29
Enrollment: 976
Sex: FEMALE
Minimum age (years): 41
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Grade 2 or 3 fibrosis 3 years after radiotherapy
timeFrame: 3 years
Secondary outcomes:
measure: Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival
timeFrame: 10 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: The Danish Breast Cancer Cooperative Group
Study officials:
affiliation: Aalborg University Hospital
name: Lars Stenbygaard, MD
role: STUDY_CHAIR
affiliation: Aarhus University Hospital
name: Birgitte Offersen, MD, Ph.D
role: STUDY_CHAIR
affiliation: Vejle Hospital
name: Erik Jakobsen, MD
role: STUDY_CHAIR
affiliation: Odense University Hospital
name: Mette H Nielsen, MD, phd
role: STUDY_CHAIR
affiliation: Aarhus University Hospital
name: Birgitte Offersen, MD, phd
role: PRINCIPAL_INVESTIGATOR
affiliation: University Clinic Carl Gustav Carus Dresden
name: Mechthild Krause, M.D., Prof
role: STUDY_CHAIR
affiliation: Praxis für Strahlentherapie am Klinikum Dresden-Friedrichstadt
name: Andreas Schreiber, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: Helse Stavanger HF, Sorlandet Sykehus HF
name: Ingvil Mjaaland, M.D.
role: STUDY_CHAIR
affiliation: Kristiansand Sykehus
name: Unn-Miriam Kasti, M.D.
role: STUDY_CHAIR
References:
citation: 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.