Clinical trial · Interventional
Phase 2 Study of Adjuvant Radiotherapy in Breast Cancer Using a Once a Week Hypofractionated Regimen
Weekly Hypofractionated Radiotherapy in Breast Cancer: a Phase 2 Clinical Trial
- 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 implementation of a weekly hypofractionated radiation could be an advantageous alternative. The convenience of less treatment days could cause a greater adherence, decrease of costs and increase the offer of radiotherapy to major number of patients in underserved areas. The purpose of this study is to determine in women with diagnosis of initial breast cancer undergoing breast-conserving surgery the effects of the adjuvant radiotherapy using a once a week regimen, with 5 fractions in total. The study will analyze the acute toxicity of radiation, the patient's self referred quality of life, the cosmetic breast appearance, as well the oncological safety. It will also be analyzed the viability of this more contracted regimen in our community setting, regarding the patient's adherence to the treatment.
Conditions
Conditions (1)
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| once-weekly breast irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Weekly radiation
- description
- once-weekly breast irradiation
- interventionNames
- Radiation: once-weekly breast irradiation
Primary outcomes (1)
- measure
- Number patients with adverse events
- timeFrame
- RT duration, 5 weeks
Secondary outcomes (5)
- measure
- Cosmetic appearance
- timeFrame
- One year
- measure
- Number of local failures after RT
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Breast carcinoma * Submitted to breast conserving surgery with pos-op free margins status * Early stage: pT1-2N0 Exclusion Criteria: * Positive pathological margins * Submitted to chemotherapy, either neoadjuvant or adjuvant * Previous breast reconstruction * Bilateral breast cancer * Previous thoracic irradiation * Collagen disease
References
Publications (4)
- BACKGROUNDFAST Trialists group; Agrawal RK, Alhasso A, Barrett-Lee PJ, Bliss JM, Bliss P, Bloomfield D, Bowen J, Brunt AM, Donovan E, Emson M, Goodman A, Harnett A, Haviland JS, Kaggwa R, Morden JP, Robinson A, Simmons S, Stewart A, Sydenham MA, Syndikus I, Tremlett J, Tsang Y, Wheatley D, Venables K, Yarnold JR. First results of the randomised UK FAST Trial of radiotherapy hypofractionation for treatment of early breast cancer (CRUKE/04/015). Radiother Oncol. 2011 Jul;100(1):93-100. doi: 10.1016/j.radonc.2011.06.026. PMID 21752481
- BACKGROUNDDragun AE, Quillo AR, Riley EC, Roberts TL, Hunter AM, Rai SN, Callender GG, Jain D, McMasters KM, Spanos WJ. A phase 2 trial of once-weekly hypofractionated breast irradiation: first report of acute toxicity, feasibility, and patient satisfaction. Int J Radiat Oncol Biol Phys. 2013 Mar 1;85(3):e123-8. doi: 10.1016/j.ijrobp.2012.10.021. Epub 2012 Nov 27. PMID 23195779
- BACKGROUNDKirova YM, Campana F, Savignoni A, Laki F, Muresan M, Dendale R, Bollet MA, Salmon RJ, Fourquet A; Institut Curie Breast Cancer Study Group. Breast-conserving treatment in the elderly: long-term results of adjuvant hypofractionated and normofractionated radiotherapy. Int J Radiat Oncol Biol Phys. 2009 Sep 1;75(1):76-81. doi: 10.1016/j.ijrobp.2008.11.005. Epub 2009 Jan 23. PMID 19168297
- DERIVEDReboucas LM, Campos CS, D'Amico GM, Lustosa AB, Fregnani JH. Once-weekly hypofractionated radiotherapy for breast cancer: First results of a phase II clinical trial. Breast J. 2019 Sep;25(5):953-957. doi: 10.1111/tbj.13372. Epub 2019 Jun 4. PMID 31165541