Clinical trial · Interventional
Hypofractionated Versus Standard Fractionated Whole Breast Irradiation to Node-negative Breast Cancer Patients
Hypofractionated Versus Standard Fractionated Whole Breast Irradiation to Node-negative Breast Cancer Patients: a Randomized Phase III Trial, CIRRO (The Lundbeck Foundation Center for International Research in Radiation Oncology)
NCT00909818CI-TRIAL-00053487unknownN/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 this study is to investigate the difference in late radiation morbidity between hypofractionated and standard fractionated breast irradiation given to women operated with breast conservation for early breast cancer.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Carcinoma in Situ of the Breast | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hypofractionated radiotherapy | Radiation | — | UNRESOLVED |
| standard fractionated radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- standard fractionated radiotherapy
- description
- 50 Gy/25 fractions, 2.00 Gy/fraction, 5 fractions per week
- interventionNames
- Radiation: standard fractionated radiotherapy
- type
- EXPERIMENTAL
- label
- hypofractionated radiotherapy
- description
- hypofractionated radiotherapy 40 Gy/15 fractions
- interventionNames
- Radiation: hypofractionated radiotherapy
Primary outcomes (1)
- measure
- Grade 2 or 3 fibrosis 3 years after radiotherapy
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 41 Years
Show eligibility criteria text
Inclusion Criteria: * operated with breast conserving strategy for: 1. invasive breast cancer, pT1-2, pN0-1mi, M0 OR 2. carcinoma in situ of the breast Exclusion Criteria: * previous radiation of the breast/thorax * breast implants * pregnant/lactating * comorbidity which may hinder the patient in completing the therapy and complete follow up for 10 years
References
Publications (1)
- DERIVEDOffersen BV, Alsner J, Nielsen HM, Jakobsen EH, Nielsen MH, Krause M, Stenbygaard L, Mjaaland I, Schreiber A, Kasti UM, Overgaard J; Danish Breast Cancer Group Radiation Therapy Committee. Hypofractionated Versus Standard Fractionated Radiotherapy in Patients With Early Breast Cancer or Ductal Carcinoma In Situ in a Randomized Phase III Trial: The DBCG HYPO Trial. J Clin Oncol. 2020 Nov 1;38(31):3615-3625. doi: 10.1200/JCO.20.01363. Epub 2020 Sep 10. PMID 32910709