Clinical trial NCT02384733: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lymphedema
Fibrosis
Keywords: Radiation induced morbidity, recurrence
Lead sponsor: Danish Breast Cancer Cooperative Group
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
First posted: 2015-03-10
Enrollment: 2963
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Development of ipsilateral arm lymphedema
timeFrame: 3 years
Secondary outcomes:
measure: Fibrosis grade 2-3
timeFrame: 3 years
measure: Arm range of motion
timeFrame: 3 years
measure: Development of dyspigmentation
timeFrame: 3 years
measure: Recurrence
timeFrame: 10 years
measure: Development of pain in the irradiated area
timeFrame: 3 years
measure: Change in sensibility
timeFrame: 3 years
measure: Development of edema on breast / chest wall
timeFrame: 3 years
measure: Development of telangiectasia in irradiated area
timeFrame: 3 years
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aalborg University Hospital
name: Lars Stenbygaard, MD
role: STUDY_CHAIR
affiliation: Vejle Hospital
name: Troels Bechmann, MD,PhD
role: STUDY_CHAIR
affiliation: Odense University Hospital
name: Mette Nielsen, MD
role: STUDY_CHAIR
affiliation: Aarhus University Hospital
name: Birgitte Offersen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarhus University Hospital
name: Hanne Nielsen, MD
role: STUDY_CHAIR
affiliation: Rigshospitalet, Denmark
name: Claus Kamby, MD
role: STUDY_CHAIR
affiliation: Naestved Hospital
name: Sami Al-Rawi, MD
role: STUDY_CHAIR
affiliation: Technische Universität Dresden Klinik und Poliklinik für Strahlentherapie und Radioonkologie
name: Mechthild Krause, MD
role: STUDY_CHAIR
affiliation: Praxis für Strahlentherapie, Dresden
name: Andreas Schreiber, MD
role: STUDY_CHAIR
affiliation: Stavanger Hospital
name: Ingvil Mjaaland, MD
role: STUDY_CHAIR
affiliation: Institute of Oncology Ljubljana
name: Tanja Marinko, MD
role: STUDY_CHAIR
affiliation: Radiotherapy Department Université Catholique de Louvain, Cliniques Universitaires St-Luc, Brussels
name: Carine Kirkove, MD
role: STUDY_CHAIR
affiliation: University Hospital of North Norway, Tromsoe
name: Egil Blix, MD
role: STUDY_CHAIR
affiliation: Kristiansand Hospital, Norway
name: Unn-Miriam Kasti
role: STUDY_CHAIR
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