Prospective Comparative Study of Hypofractionated Adjuvant Radiotherapy in 2 Virsus 3 Weeks in Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: radiotherapy.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Female breast cancer (BC) has been the leading cause of cancer morbidity and mortality among women in the
majority of countries for decades. In 2020, there were an estimated 2.3 million new cases and 685,000 deaths
from female BC worldwide, which accounted for one in four cancer cases and one in six cancer deaths among
women.
u For women with newly diagnosed, non-metastatic breast cancer, treatment consists of a multidisciplinary
approach that involves input from surgery, radiation oncology, and medical oncology. The objective of adjuvant
radiation therapy (RT) is to eradicate any tumor deposits remaining following surgery for patients treated by
either breast-conserving surgery or mastectomy . Doing so reduces risk of locoregional recurrence and improves
breast cancer-specific and overall survivals.
u A historical regimen of 25-28 fractions over 6 weeks was adopted for radiotherapy (RT) following breast-
conserving surgery (BCS) and total mastectomy. An early assumption that breast cancer cell lines might be more
sensitive to fractional doses than acute skin reactions and other squamous carcinomas lead to development of the
hypofractionated RT (HypoRT) approach, which elevated fractional dose up to 3 Gy with reduced total
dose/fractions, for obtaining radiobiological equivalence to a traditional regimen of 50-50.4 Gy in 25-28
fractions.
u Recently, the American Society of Radiation Oncology released a task force guideline recommending
hypofractionated radiotherapy for all women of any age whether they had received chemotherapy or not ,Their
evidence-based recommendations were supported by studies from Canada and the United Kingdom.
u Benefits of HypoRT include both, radiobiologic advantages and reduced length of treatment courses, for
improving healthcare resources and patient convenience. Consequently, HypoRT has been widely adopted
worldwide based on a series of randomized clinical trials .
u Recently, HypoRT over 3 weeks and with shorter courses of 5 fractions have been recommended in treatment
guidelines.
u Regarding clinical outcomes of a 2-week fractionation schedule , it was observed that acute and late effects were
acceptable with control rates similar to those reported in other trials with hypofractionation,Based
on these findings we started a trial to compare a 3-week radiotherapy schedule with a 2-week schedule .
Interventions
- Device radiotherapy
Hypofractionated Adjuvant Radiotherapy in 2 versus 3 Weeks of Breast Cancer and effect skin toxicity and over all survival
Primary outcome measures
- Disease free survival analyzed from the date of diagnosis. [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (2)
- Assessment of Acute Skin Toxicity [Time frame: From start of radiotherapy through 3 months after completion of radiotherapy]
- Assessment of Late Skin Toxicity [Time frame: From 3 months after completion of radiotherapy through study completion, an average of 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Egypt · 1 center
- Assuit — Asyut
Publications
- Youssef 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
- Eraso 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
- Kim 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
- Yadav 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
- START 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 PMID 18356109
- Zhang 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. PMID 40693239
Identifiers
NCT: NCT07344597 · adjuvant radiotherapy in BC