Clinical trial · Interventional
Accelerated Hypofractionated 1 Week Radiotherapy in Breast Cancer Patients
NCT05591456CI-TRIAL-00061677completedPhase 3ClinicalTrials.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)
Accelerated hypofractionated 1 week post-mastectomy chest wall irradiation in breast cancer patients will presumably produce comparable toxicity and disease control in comparison to 3 weeks schedule. The aim is to evaluate toxicity and disease control after implementation of accelerated hypofractionated 1 week chest wall irradiation in breast cancer patients.
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 Cancer Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- group 1
- description
- The first group 50 patient (arm A) will receive a dose of 27 Gy to the chest wall using 3D conformal radiotherapy (5.4 Gy per fraction) over one week,
- interventionNames
- Radiation: adjuvant radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- group 2
- description
- the second group 50 patient (arm B) will receive a dose of 40 Gy to the chest wall (2.67 Gy per fraction) over three weeks.
- interventionNames
- Radiation: adjuvant radiotherapy
Primary outcomes (6)
- measure
- detection of breast shrinkage
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * histological diagnosis of breast adenocarcinoma * prior modified radical mastectomy * negative resection margins (3 mm) * pathological stage pT1-pT2, N0-2 (AJCC, 2017) * no macroscopic evidence of distant metastases at diagnosis * Age 18-80 years * Normal hematological and biochemical laboratory tests * Written informed consent was obtained from all patients Exclusion Criteria: * locally advanced disease pT3-pT4, N3 * positive surgical margins * prior thoracic radiation * synchronous second primary tumor * distant metastases * pregnancy * presence of a concomitant psychiatric disorder precluding an aware informed consent. * age \>80 years
References
Publications (6)
- BACKGROUNDSung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID 33538338
- BACKGROUNDAsh DV, Benson EA, Sainsbury JR, Round C, Head C. Seven-year follow-up on 334 patients treated by breast conserving surgery and short course radical postoperative radiotherapy: a report of the Yorkshire Breast Cancer Group. Clin Oncol (R Coll Radiol). 1995;7(2):93-6. doi: 10.1016/s0936-6555(05)80808-8. PMID 7619770
- BACKGROUNDIbrahim AS, Khaled HM, Mikhail NN, Baraka H, Kamel H. Cancer incidence in egypt: results of the national population-based cancer registry program. J Cancer Epidemiol. 2014;2014:437971. doi: 10.1155/2014/437971. Epub 2014 Sep 21. PMID 25328522
- BACKGROUNDFajdic J, Djurovic D, Gotovac N, Hrgovic Z. Criteria and procedures for breast conserving surgery. Acta Inform Med. 2013 Mar;21(1):16-9. doi: 10.5455/AIM.2013.21.16-19. PMID 23572855
- BACKGROUNDAleknavicius E, Atkocius V, Kuzmickiene I, Steponaviciene R. Postmastectomy internal mammary nodal irradiation: a long-term outcome. Medicina (Kaunas). 2014;50(4):230-6. doi: 10.1016/j.medici.2014.09.010. Epub 2014 Oct 7. PMID 25458960
- BACKGROUNDMannino M, Yarnold JR. Shorter fractionation schedules in breast cancer radiotherapy: clinical and economic implications. Eur J Cancer. 2009 Mar;45(5):730-1. doi: 10.1016/j.ejca.2009.01.024. Epub 2009 Feb 23. No abstract available. PMID 19243933