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

Primary Purpose

Breast Cancer, Carcinoma in Situ of the Breast

Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
standard fractionated radiotherapy
hypofractionated radiotherapy
Sponsored by
Danish Breast Cancer Cooperative Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

41 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • The Danish Breast Cancer Cooperative Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

standard fractionated radiotherapy

hypofractionated radiotherapy

Arm Description

50 Gy/25 fractions, 2.00 Gy/fraction, 5 fractions per week

hypofractionated radiotherapy 40 Gy/15 fractions

Outcomes

Primary Outcome Measures

Grade 2 or 3 fibrosis 3 years after radiotherapy

Secondary Outcome Measures

Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival

Full Information

First Posted
May 28, 2009
Last Updated
August 23, 2021
Sponsor
Danish Breast Cancer Cooperative Group
Collaborators
Danish Cancer Society
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1. Study Identification

Unique Protocol Identification Number
NCT00909818
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 14, 2009 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Breast Cancer Cooperative Group
Collaborators
Danish Cancer Society

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Carcinoma in Situ of the Breast

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
976 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard fractionated radiotherapy
Arm Type
Active Comparator
Arm Description
50 Gy/25 fractions, 2.00 Gy/fraction, 5 fractions per week
Arm Title
hypofractionated radiotherapy
Arm Type
Experimental
Arm Description
hypofractionated radiotherapy 40 Gy/15 fractions
Intervention Type
Radiation
Intervention Name(s)
standard fractionated radiotherapy
Intervention Description
standard fractionated radiotherapy 50 Gy/25 fractions
Intervention Type
Radiation
Intervention Name(s)
hypofractionated radiotherapy
Intervention Description
hypofractionated radiotherapy 40 Gy/15 fractions
Primary Outcome Measure Information:
Title
Grade 2 or 3 fibrosis 3 years after radiotherapy
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival
Time Frame
10 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
41 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: operated with breast conserving strategy for: invasive breast cancer, pT1-2, pN0-1mi, M0 OR 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Stenbygaard, MD
Organizational Affiliation
Aalborg University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Birgitte Offersen, MD, Ph.D
Organizational Affiliation
Aarhus University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Erik Jakobsen, MD
Organizational Affiliation
Vejle Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mette H Nielsen, MD, phd
Organizational Affiliation
Odense University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Birgitte Offersen, MD, phd
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mechthild Krause, M.D., Prof
Organizational Affiliation
University Clinic Carl Gustav Carus Dresden
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Andreas Schreiber, M.D., Ph.D.
Organizational Affiliation
Praxis für Strahlentherapie am Klinikum Dresden-Friedrichstadt
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ingvil Mjaaland, M.D.
Organizational Affiliation
Helse Stavanger HF, Sorlandet Sykehus HF
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Unn-Miriam Kasti, M.D.
Organizational Affiliation
Kristiansand Sykehus
Official's Role
Study Chair
Facility Information:
Facility Name
The Danish Breast Cancer Cooperative Group
City
Copenhagen
ZIP/Postal Code
DK-2100 Ø
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
32910709
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.
Results Reference
derived

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

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