LymphedemaNCT02384733
Hypofractionated Loco-regional Adjuvant Radiation Therapy of Breast Cancer Combined With a Simultaneous Integrated Boost
A study testing Loco-regional RT in people with Lymphedema and Fibrosis, run by Danish Breast Cancer Cooperative Group at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lymphedema, Fibrosis
- What is being tested?
- Loco-regional RT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,963 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2015to 1 Jul 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Operated for early node-positive breast cancer with indication for loco-regional breast radiotherapy
Who cannot join
- Previous radiotherapy to chest wall, pregnant/lactating, comorbidity which may hinder 10 years follow up
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Loco-regional RT
- Keywords
- Radiation induced morbidity, recurrence
- Medical subject headings
- Lymphedema, Fibrosis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loco-regional RTRadiation
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated loco-regional RT | Experimental | 40 Gy / 15 fractions, 2.67 Gy per fraction, 5 fractions weekly Receives: Radiation: Loco-regional RT |
| Normofractionated loco-regional RT | Active comparator | 50 Gy / 25 fractions, 2.00 Gy per fraction, 5 fractions weekly Receives: Radiation: Loco-regional RT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of ipsilateral arm lymphedema
>=10% increased arm circumference compared to the other arm defines edema
Measured: 3 years
Secondary outcomes (8)
Fibrosis grade 2-3
Breast or chest wall induration
Measured: 3 years
Arm range of motion
Impaired shoulder movement is present when >20 degrees difference between arms at flexion and/or abduction
Measured: 3 years
Development of dyspigmentation
Grade 2 or worse dyspigmentation compared to baseline
Measured: 3 years
Recurrence
Any recurrence location and time to event
Measured: 10 years
Development of pain in the irradiated area
Pain in the irradiated area measured on visual analog scale compared to baseline
Measured: 3 years
Change in sensibility
Change in sensibility in the irradiated area compared to baseline measured as yes/no
Measured: 3 years
Development of edema on breast / chest wall
Grade 2 or worse edema
Measured: 3 years
Development of telangiectasia in irradiated area
Grade 2 or worse telangiectasia
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study startMar 2015
- Primary completion1 Jul 2021
- Study completion1 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,963 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Breast Cancer Cooperative Group
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society
- Responsible party
- Principal investigator, Birgitte Offersen, Danish Breast Cancer Cooperative Group
- Investigators
- Lars Stenbygaard, MD, Study chair, Aalborg University HospitalTroels Bechmann, MD,PhD, Study chair, Vejle HospitalMette Nielsen, MD, Study chair, Odense University HospitalBirgitte Offersen, MD, Principal investigator, Aarhus University HospitalHanne Nielsen, MD, Study chair, Aarhus University HospitalClaus Kamby, MD, Study chair, Copenhagen University Hospital, RigshospitaletSami Al-Rawi, MD, Study chair, Naestved HospitalMechthild Krause, MD, Study chair, Technische Universität Dresden Klinik und Poliklinik für Strahlentherapie und Radioonkologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02384733
- Sponsor's protocol ID
- The Skagen Trial 1
- Status last verified
- Jul 2021
- First submitted
- 19 Feb 2015
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Offersen BV, Alsner J, Hogsbjerg K, Nielsen HM, Maae E, Nielsen MH, Mjaaland I, Maraldo MV, Kirkove C, Lorincz T, Al-Rawi S, Blix ES, Schreiber A, Krause M, Kasti UM, Matthiessen LW, Kronborg C, Tramm T, Jensen MB, Overgaard J; DBCG RT Committee. Hypo- Versus Standard Fractionated Locoregional Radiotherapy of Patients With High-Risk Breast Cancer in the Randomized Phase III Trial: The Danish Breast Cancer Group Skagen Trial 1. J Clin Oncol. 2026 Aug 20;44(24):2278-2289. doi: 10.1200/JCO-25-02705. Epub 2026 Jul 23.
PubMed 42492022
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02384733
- Acronym / sponsor ID
- The Skagen Trial 1
- Conditions
- Lymphedema, Fibrosis
- Keywords
- Radiation induced morbidity, recurrence
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,963 participants (actual)
- Lead sponsor
- Danish Breast Cancer Cooperative GroupUniversity, hospital or other
- Collaborators
- Danish Cancer Society
- Study start
- Mar 2015 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2032 (estimated)
- First posted
- 10 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated loco-regional RT | Experimental | Radiation: Loco-regional RT40 Gy / 15 fractions, 2.67 Gy per fraction, 5 fractions weekly |
| Normofractionated loco-regional RT | Active comparator | Radiation: Loco-regional RT50 Gy / 25 fractions, 2.00 Gy per fraction, 5 fractions weekly |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Operated for early node-positive breast cancer with indication for loco-regional breast radiotherapy
Key exclusion criteria (1 listed)
- Previous radiotherapy to chest wall, pregnant/lactating, comorbidity which may hinder 10 years follow up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Loco-regional RT | Radiation | Hypofractionated loco-regional RT, Normofractionated loco-regional RT |
Primary outcome
Development of ipsilateral arm lymphedema
Time frame: 3 years
>=10% increased arm circumference compared to the other arm defines edema
8 secondary outcomes
Fibrosis grade 2-3
Time frame: 3 years
Arm range of motion
Time frame: 3 years
Development of dyspigmentation
Time frame: 3 years
Recurrence
Time frame: 10 years
Development of pain in the irradiated area
Time frame: 3 years
Change in sensibility
Time frame: 3 years
Development of edema on breast / chest wall
Time frame: 3 years
Development of telangiectasia in irradiated area
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Derived from this study: PubMed 42492022Offersen BV, Alsner J, Hogsbjerg K, Nielsen HM, Maae E, Nielsen MH, Mjaaland I, Maraldo MV, Kirkove C, Lorincz T, Al-Rawi S, Blix ES, Schreiber A, Krause M, Kasti UM, Matthiessen LW, Kronborg C, Tramm T, Jensen MB, Overgaard J; DBCG RT Committee. Hypo- Versus Standard Fractionated Locoregional Radiotherapy of Patients With High-Risk Breast Cancer in the Randomized Phase III Trial: The Danish Breast Cancer Group Skagen Trial 1. J Clin Oncol. 2026 Aug 20;44(24):2278-2289. doi: 10.1200/JCO-25-02705. Epub 2026 Jul 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Stenbygaard, MD study chair
Aalborg University Hospital
Troels Bechmann, MD,PhD study chair
Vejle Hospital
Mette Nielsen, MD study chair
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Loco-regional RT in people with Lymphedema and Fibrosis, run by Danish Breast Cancer Cooperative Group at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of ipsilateral arm lymphedema (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02384733, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2021.