Back to resultsHypofractionated Loco-regional Adjuvant Radiation Therapy of Breast Cancer Combined With a Simultaneous Integrated Boost
Primary Purpose
Lymphedema, Fibrosis
Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Loco-regional RT
Sponsored by
About this trial
This is an interventional treatment trial for Lymphedema focused on measuring Radiation induced morbidity, recurrence
Eligibility Criteria
Inclusion Criteria:
Operated for early node-positive breast cancer with indication for loco-regional breast radiotherapy
Exclusion Criteria:
Previous radiotherapy to chest wall, pregnant/lactating, comorbidity which may hinder 10 years follow up
Sites / Locations
- Aarhus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hypofractionated loco-regional RT
Normofractionated loco-regional RT
Arm Description
40 Gy / 15 fractions, 2.67 Gy per fraction, 5 fractions weekly
50 Gy / 25 fractions, 2.00 Gy per fraction, 5 fractions weekly
Outcomes
Primary Outcome Measures
Development of ipsilateral arm lymphedema
>=10% increased arm circumference compared to the other arm defines edema
Secondary Outcome Measures
Fibrosis grade 2-3
Breast or chest wall induration
Arm range of motion
Impaired shoulder movement is present when >20 degrees difference between arms at flexion and/or abduction
Development of dyspigmentation
Grade 2 or worse dyspigmentation compared to baseline
Recurrence
Any recurrence location and time to event
Development of pain in the irradiated area
Pain in the irradiated area measured on visual analog scale compared to baseline
Change in sensibility
Change in sensibility in the irradiated area compared to baseline measured as yes/no
Development of edema on breast / chest wall
Grade 2 or worse edema
Development of telangiectasia in irradiated area
Grade 2 or worse telangiectasia
Full Information
NCT ID
NCT02384733
First Posted
February 19, 2015
Last Updated
July 7, 2021
Sponsor
Danish Breast Cancer Cooperative Group
Collaborators
Danish Cancer Society
1. Study Identification
Unique Protocol Identification Number
NCT02384733
Brief Title
Hypofractionated Loco-regional Adjuvant Radiation Therapy of Breast Cancer Combined With a Simultaneous Integrated Boost
Official Title
The Skagen Trial 1, Moderately Hypofractionated Loco-regional Adjuvant Radiation Therapy of Early Breast Cancer Combined With a Simultaneous Integrated Boost: a Randomised Clinically Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2015 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 1, 2032 (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 the study is to investigate the difference in late radiation morbidity between hypofractionated and normofractionated loco-regional breast irradiation irrespective of mastectomy or lumpectomy. In patients who a candidates for a boost, the boost will be provided as a simultaneous integrated boost.
Detailed Description
The randomization is between 50 Gy / 25 fractions and 40 Gy/15 fractions, 5 fractions weekly. In patients treated with boost 2 dose levels are accepted: 16 Gy/8 fractions and 10 Gy/5 fractions. These boost treatments will be provided as simultaneous integrated boost, where the overall treatment time in general is shortened 5 days. Thus the dose levels for boost patients are:
63 Gy / 51.52 Gy / 28 fractions, 57 Gy / 50 Gy / 25 fractions, 52.2 Gy / 42.3 Gy / 18 fractions, and 45.75 Gy / 40 Gy / 15 fractions.
The primary endpoint is arm lymphedema 3 years after radiation therapy, but other late radiation morbidities will also be evaluated along with recurrence and sites of recurrence. Follow up of morbidity will continue for 10 years.
The hypothesis is that women operated for early breast cancer with indication for loco-regional radiation therapy can be offered moderately hypofractionated therapy without developing more late radiation induced morbidity compared to normofractionated radiation therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema, Fibrosis
Keywords
Radiation induced morbidity, recurrence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2963 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hypofractionated loco-regional RT
Arm Type
Experimental
Arm Description
40 Gy / 15 fractions, 2.67 Gy per fraction, 5 fractions weekly
Arm Title
Normofractionated loco-regional RT
Arm Type
Active Comparator
Arm Description
50 Gy / 25 fractions, 2.00 Gy per fraction, 5 fractions weekly
Intervention Type
Radiation
Intervention Name(s)
Loco-regional RT
Primary Outcome Measure Information:
Title
Development of ipsilateral arm lymphedema
Description
>=10% increased arm circumference compared to the other arm defines edema
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Fibrosis grade 2-3
Description
Breast or chest wall induration
Time Frame
3 years
Title
Arm range of motion
Description
Impaired shoulder movement is present when >20 degrees difference between arms at flexion and/or abduction
Time Frame
3 years
Title
Development of dyspigmentation
Description
Grade 2 or worse dyspigmentation compared to baseline
Time Frame
3 years
Title
Recurrence
Description
Any recurrence location and time to event
Time Frame
10 years
Title
Development of pain in the irradiated area
Description
Pain in the irradiated area measured on visual analog scale compared to baseline
Time Frame
3 years
Title
Change in sensibility
Description
Change in sensibility in the irradiated area compared to baseline measured as yes/no
Time Frame
3 years
Title
Development of edema on breast / chest wall
Description
Grade 2 or worse edema
Time Frame
3 years
Title
Development of telangiectasia in irradiated area
Description
Grade 2 or worse telangiectasia
Time Frame
3 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Operated for early node-positive breast cancer with indication for loco-regional breast radiotherapy
Exclusion Criteria:
Previous radiotherapy to chest wall, pregnant/lactating, comorbidity which may hinder 10 years follow up
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
Troels Bechmann, MD,PhD
Organizational Affiliation
Vejle Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mette Nielsen, MD
Organizational Affiliation
Odense University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Birgitte Offersen, MD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hanne Nielsen, MD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Claus Kamby, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sami Al-Rawi, MD
Organizational Affiliation
Naestved Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mechthild Krause, MD
Organizational Affiliation
Technische Universität Dresden Klinik und Poliklinik für Strahlentherapie und Radioonkologie
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Andreas Schreiber, MD
Organizational Affiliation
Praxis für Strahlentherapie, Dresden
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ingvil Mjaaland, MD
Organizational Affiliation
Stavanger Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tanja Marinko, MD
Organizational Affiliation
Institute of Oncology Ljubljana
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Carine Kirkove, MD
Organizational Affiliation
Radiotherapy Department Université Catholique de Louvain, Cliniques Universitaires St-Luc, Brussels
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Egil Blix, MD
Organizational Affiliation
University Hospital of North Norway, Tromsoe
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Unn-Miriam Kasti
Organizational Affiliation
Kristiansand Hospital, Norway
Official's Role
Study Chair
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Hypofractionated Loco-regional Adjuvant Radiation Therapy of Breast Cancer Combined With a Simultaneous Integrated Boost
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