Hypofractionated Loco-regional Adjuvant Radiation Therapy of Breast Cancer Combined With a Simultaneous Integrated Boost

NCT ID: NCT02384733

Last Updated: 2021-07-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2963 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2032-07-01

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.

Conditions

Lymphedema; Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hypofractionated loco-regional RT

40 Gy / 15 fractions, 2.67 Gy per fraction, 5 fractions weekly

Group Type: EXPERIMENTAL

Loco-regional RT

Intervention Type: RADIATION

Normofractionated loco-regional RT

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

Group Type: ACTIVE_COMPARATOR

Loco-regional RT

Intervention Type: RADIATION

Interventions

Loco-regional RT

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Danish Cancer Society

OTHER

Sponsor Role: collaborator

Danish Breast Cancer Cooperative Group

OTHER

Sponsor Role: lead

Responsible Party

Birgitte Offersen

MD, professor, ph.d.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lars Stenbygaard, MD

Role: STUDY_CHAIR

Aalborg University Hospital

Troels Bechmann, MD,PhD

Role: STUDY_CHAIR

Vejle Hospital

Mette Nielsen, MD

Role: STUDY_CHAIR

Odense University Hospital

Birgitte Offersen, MD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Hanne Nielsen, MD

Role: STUDY_CHAIR

Aarhus University Hospital

Claus Kamby, MD

Role: STUDY_CHAIR

Rigshospitalet, Denmark

Sami Al-Rawi, MD

Role: STUDY_CHAIR

Naestved Hospital

Mechthild Krause, MD

Role: STUDY_CHAIR

Technische Universität Dresden Klinik und Poliklinik für Strahlentherapie und Radioonkologie

Andreas Schreiber, MD

Role: STUDY_CHAIR

Praxis für Strahlentherapie, Dresden

Ingvil Mjaaland, MD

Role: STUDY_CHAIR

Stavanger Hospital

Tanja Marinko, MD

Role: STUDY_CHAIR

Institute of Oncology Ljubljana

Carine Kirkove, MD

Role: STUDY_CHAIR

Radiotherapy Department Université Catholique de Louvain, Cliniques Universitaires St-Luc, Brussels

Egil Blix, MD

Role: STUDY_CHAIR

University Hospital of North Norway, Tromsoe

Unn-Miriam Kasti

Role: STUDY_CHAIR

Kristiansand Hospital, Norway

Locations

Aarhus University Hospital

Aarhus, , Denmark

Countries

Denmark

Other Identifiers

The Skagen Trial 1

Identifier Type: -

Identifier Source: org_study_id