| Autor: |
R. Saúde-Conde, T. Vandamme, M. De Backer, P. Martinive, A. Covas, A. Deleporte, A. Dermine, F. Forget, K. Geboes, Q. Gilliaux, Y. Gokburun, E. Gonne, I. Joye, S. Lecomte, G. Liberale, W. Lybaert, L. Moretti, L. Mortier, S. Mupingu Mwanawa, F. Puleo, E.D. Saad, I. Sinapi, L. Annemans, M. Buyse, F. Sclafani |
| Jazyk: |
angličtina |
| Rok vydání: |
2024 |
| Předmět: |
|
| Zdroj: |
ESMO Gastrointestinal Oncology, Vol 4, Iss , Pp 100067- (2024) |
| Druh dokumentu: |
article |
| ISSN: |
2949-8198 |
| DOI: |
10.1016/j.esmogo.2024.100067 |
| Popis: |
Although total neoadjuvant therapy (TNT) is a new standard of care for locally advanced rectal cancer (LARC), there are no data to confirm the safety and efficacy of this approach in older patients. SHAPERS is a multicentre, open-label, randomised pragmatic trial, aiming to assess whether neoadjuvant short-course radiotherapy (SCRT) is a better trade-off between safety and efficacy than TNT in LARC patients aged ≥70 years. Eligible patients are randomised in a 1 : 1 ratio to SCRT followed by surgery [or watch & wait (w&w)] ± adjuvant chemotherapy or TNT (either SCRT followed by 12-18 weeks of chemotherapy, or long-course chemoradiotherapy followed or preceded by 16 weeks of chemotherapy, based on the investigator’s choice) followed by surgery (or w&w). The primary endpoint is the net treatment benefit, a multicomponent measure of treatment effect based on generalised pairwise comparisons, and defined by four prioritised outcome measures: (i) overall survival at 3 years; (ii) progression-free survival at 3 years; (iii) increased-grade peripheral sensory neuropathy at 3 years; (iv) grade ≥3 toxicities during treatment. The study sample size includes 230 eligible patients, to be recruited at 15-20 centres in Belgium. The trial is registered with ClinicalTrials.gov (NCT06052332). |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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