Efficacy and safety of short-course radiotherapy versus total neoadjuvant therapy in older rectal cancer patients: a randomised pragmatic trial (SHAPERS)

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 , F. Sclafani
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Abstract

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).

Abstract Image

老年直肠癌患者接受短程放疗与全面新辅助治疗的疗效和安全性:随机实用性试验(SHAPERS)
尽管新辅助治疗(TNT)是治疗局部晚期直肠癌(LARC)的新标准,但目前尚无数据证实这种方法对老年患者的安全性和有效性。SHAPERS是一项多中心、开放标签、随机的实用性试验,旨在评估在年龄≥70岁的LARC患者中,新辅助短程放疗(SCRT)是否比TNT更能权衡安全性和有效性。符合条件的患者将按1:1的比例随机接受SCRT后手术[或观察&等待(w&w)]±辅助化疗或TNT(根据研究者的选择,SCRT后进行12-18周的化疗,或长程化放疗后进行或先进行16周的化疗)后手术(或w&w)。主要终点是治疗净获益,这是一种基于广义配对比较的多组分治疗效果衡量方法,由四个优先结果指标定义:(i) 3 年的总生存期;(ii) 3 年的无进展生存期;(iii) 3 年的外周感觉神经病变加重;(iv) 治疗期间毒性≥3 级。研究样本包括230名符合条件的患者,将在比利时的15-20个中心招募。该试验已在 ClinicalTrials.gov 注册(NCT06052332)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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