Hypofractionated Loco-regional Adjuvant Radiation Therapy of Breast Cancer Combined With a Simultaneous Integrated Boost
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ClinicalTrials.gov Identifier: NCT02384733 |
Recruitment Status :
Recruiting
First Posted : March 10, 2015
Last Update Posted : February 25, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lymphedema Fibrosis | Radiation: Loco-regional RT | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 2000 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | March 2015 |
Estimated Primary Completion Date : | March 2022 |
Estimated Study Completion Date : | March 2036 |
Arm | Intervention/treatment |
---|---|
Experimental: Hypofractionated loco-regional RT
40 Gy / 15 fractions, 2.67 Gy per fraction, 5 fractions weekly
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Radiation: Loco-regional RT |
Active Comparator: Normofractionated loco-regional RT
50 Gy / 25 fractions, 2.00 Gy per fraction, 5 fractions weekly
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Radiation: Loco-regional RT |
- Development of ipsilateral arm lymphedema [ Time Frame: 3 years ]>=10% increased arm circumference compared to the other arm defines edema
- Fibrosis grade 2-3 [ Time Frame: 3 years ]Breast or chest wall induration
- Arm range of motion [ Time Frame: 3 years ]Impaired shoulder movement is present when >20 degrees difference between arms at flexion and/or abduction
- Development of dyspigmentation [ Time Frame: 3 years ]Grade 2 or worse dyspigmentation compared to baseline
- Recurrence [ Time Frame: 10 years ]Any recurrence location and time to event
- Development of pain in the irradiated area [ Time Frame: 3 years ]Pain in the irradiated area measured on visual analog scale compared to baseline
- Change in sensibility [ Time Frame: 3 years ]Change in sensibility in the irradiated area compared to baseline measured as yes/no
- Development of edema on breast / chest wall [ Time Frame: 3 years ]Grade 2 or worse edema
- Development of telangiectasia in irradiated area [ Time Frame: 3 years ]Grade 2 or worse telangiectasia

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02384733
Contact: Birgitte V. Offersen, MD, Ph.D | +45 7846 2547 | birgoffe@rm.dk | |
Contact: Hanne M. Nielsen, MD, Ph.D | +45 7846 2547 | haniesen@rm.dk |
Denmark | |
Aarhus University Hospital | Recruiting |
Aarhus, Denmark | |
Contact: Birgitte Offersen, MD birgoffe@rm.dk | |
Contact: Hanne Nielsen, MD haniesen@rm.dk |
Study Chair: | Lars Stenbygaard, MD | Aalborg University Hospital | |
Study Chair: | Troels Bechmann, MD,PhD | Vejle Hospital | |
Study Chair: | Mette Nielsen, MD | Odense University Hospital | |
Principal Investigator: | Birgitte Offersen, MD | Aarhus University Hospital | |
Study Chair: | Hanne Nielsen, MD | Aarhus University Hospital | |
Study Chair: | Claus Kamby, MD | Rigshospitalet, Denmark | |
Study Chair: | Sami Al-Rawi, MD | Naestved Hospital | |
Study Chair: | Mechthild Krause, MD | Technische Universität Dresden Klinik und Poliklinik für Strahlentherapie und Radioonkologie | |
Study Chair: | Andreas Schreiber, MD | Praxis für Strahlentherapie, Dresden | |
Study Chair: | Ingvil Mjaaland, MD | Stavanger Hospital | |
Study Chair: | Tanja Marinko, MD | Institute of Oncology Ljubljana | |
Study Chair: | Carine Kirkove, MD | Radiotherapy Department Université Catholique de Louvain, Cliniques Universitaires St-Luc, Brussels | |
Study Chair: | Egil Blix, MD | University Hospital of North Norway, Tromsoe | |
Study Chair: | Unn-Miriam Kasti | Kristiansand Hospital, Norway |
Responsible Party: | Birgitte Offersen, MD, professor, ph.d., Danish Breast Cancer Cooperative Group |
ClinicalTrials.gov Identifier: | NCT02384733 |
Other Study ID Numbers: |
The Skagen Trial 1 |
First Posted: | March 10, 2015 Key Record Dates |
Last Update Posted: | February 25, 2020 |
Last Verified: | February 2020 |
Radiation induced morbidity, recurrence |
Lymphedema Lymphatic Diseases |