Clinical trial · Interventional
Hypofractionated Loco-regional Adjuvant Radiation Therapy of Breast Cancer Combined With a Simultaneous Integrated Boost
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
NCT02384733CI-TRIAL-00052584active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fibrosis | — | UNRESOLVED | — |
| Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Loco-regional RT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hypofractionated loco-regional RT
- description
- 40 Gy / 15 fractions, 2.67 Gy per fraction, 5 fractions weekly
- interventionNames
- Radiation: Loco-regional RT
- type
- ACTIVE_COMPARATOR
- label
- Normofractionated loco-regional RT
- description
- 50 Gy / 25 fractions, 2.00 Gy per fraction, 5 fractions weekly
- interventionNames
- Radiation: Loco-regional RT
Primary outcomes (1)
- measure
- Development of ipsilateral arm lymphedema
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDOffersen 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. PMID 42492022