Clinical trial · Observational
Prospective Comparative Study of Hypofractionated Adjuvant Radiotherapy in 2 Virsus 3 Weeks in Breast Cancer
NCT07344597CI-TRIAL-00100985not yet recruitingClinicalTrials.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)
To compare the efficacy and safety of two hypofractionated adjuvant radiotherapy regimens 34 Gy in 10 fractions versus 40.05 Gy in 15 fractions in patients with breast cancer treated at the South Egypt Cancer Institute.
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 | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiotherapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- A
- description
- hypofractionated adjuvant radiotherapy regimens 40.05 Gy in 15 fractions in breast cancer in 3w
- interventionNames
- Device: radiotherapy
- label
- B
- description
- hypofractionated adjuvant radiotherapy regimens 34 Gy in 10 fractions in 2w
- interventionNames
- Device: radiotherapy
Primary outcomes (1)
- measure
- Disease free survival analyzed from the date of diagnosis.
- timeFrame
- through study completion, an average of 1 year
- description
- local control was defined as absence of disease in the irradiated areas.recurrence were categorized as local(breast or surgical bed), regional(lymphatic drainage of axillary, supraclavicular fossa or internal mammary chain),or distant (metastasis),and any associayion of these
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients aged ≥18 years. Female or male patients with invasive carcinoma of the breast. Complete microscopic excision of primary tumor. Undergoing breast-conserving surgery (BCS) or modified radical mastectomy (MRM). ≥ Axillary lymph nodes dissected. T1\_4pN0\_3M0 disease. Neoadjuvant or adjuvant CTH . Signed informed consent and able to comply with follow up. Exclusion Criteria: * Evidence of distant metastases. Past history of malignancy. Prior radiotherapy to the chest region Simultaneous malignancy (except non-melanoma skin cancer or in situ cervical carcinoma) Connective tissue diseases (e.g., lupus erythematosus, scleroderma) Pregnancy or lactation
References
Publications (6)
- RESULTYoussef A, Stanford J. Hypofractionation Radiotherapy vs. Conventional Fractionation for Breast Cancer: A Comparative Review of Toxicity. Cureus. 2018 Oct 29;10(10):e3516. doi: 10.7759/cureus.3516. PMID 30648051
- RESULTEraso A, Sanz J, Molla M, Reyes V, Pedro A, Arenas M, Martinez E, Ballester R, Cambra MJ, Garcia V, Prades JL, Borras JM, Algara M. Evidence-based guidelines for hypofractionated radiation in breast cancer: conclusions of the Catalan expert working group. Clin Transl Oncol. 2022 Aug;24(8):1580-1587. doi: 10.1007/s12094-022-02798-8. Epub 2022 Feb 21. PMID 35190961
- RESULTKim N, Kim YB. Journey to hypofractionation in radiotherapy for breast cancer: critical reviews for recent updates. Radiat Oncol J. 2022 Dec;40(4):216-224. doi: 10.3857/roj.2022.00577. Epub 2022 Dec 26. PMID 36606299
- RESULTYadav BS, Dahiya D, Gupta A, Rana D, Robert N, Sharma M, Rao B. Breast cancer hypofractionated radiotherapy in 2-weeks with 2D technique: 5-year clinical outcomes of a phase 2 trial. Rep Pract Oncol Radiother. 2021 Aug 12;26(4):503-511. doi: 10.5603/RPOR.a2021.0054. eCollection 2021. PMID 34434565
- RESULTSTART Trialists' Group; Bentzen SM, Agrawal RK, Aird EG, Barrett JM, Barrett-Lee PJ, Bliss JM, Brown J, Dewar JA, Dobbs HJ, Haviland JS, Hoskin PJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Morgan DA, Owen JR, Simmons S, Sumo G, Sydenham MA, Venables K, Yarnold JR. The UK Standardisation of Breast Radiotherapy (START) Trial A of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial. Lancet Oncol. 2008 Apr;9(4):331-41. doi: 10.1016/S1470-2045(08)70077-9. Epub 2008 Mar 19. PMID 18356109
- RESULTZhang Y, Ji Y, Liu S, Li J, Wu J, Jin Q, Liu X, Duan H, Feng Z, Liu Y, Zhang Y, Lyu Z, Song F, Song F, Yang L, Liu H, Huang Y. Global burden of female breast cancer: new estimates in 2022, temporal trend and future projections up to 2050 based on the latest release from GLOBOCAN. J Natl Cancer Cent. 2025 Feb 13;5(3):287-296. doi: 10.1016/j.jncc.2025.02.002. eCollection 2025 Jun.