No operation after short-course radiotherapy followed by consolidation chemotherapy in locally advanced rectal cancer (NOAHS-ARC): study protocol for a prospective, phase II trial.

IF 2.5 3区医学 Q2 GASTROENTEROLOGY & HEPATOLOGY

International Journal of Colorectal Disease Pub Date : 2025-03-18 DOI:10.1007/s00384-025-04850-9

Felipe F Quezada-Díaz, Aron Bercz, Jose L Escobar, Nicole Caire, Lucia E Díaz-Feldman, Erik Manriquez, Gonzalo Carvajal

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引用次数: 0

Abstract

Purpose: Organ preservation through a watch-and-wait (W&W) strategy has become a viable option for select rectal cancer patients with clinical complete responses (cCR) to total neoadjuvant therapy (TNT). This approach limits the morbidity associated with multimodal treatment. However, the optimal treatment strategy and predictors of treatment response are still unresolved. Rectal cancer incidence is rising, particularly in developing countries, and the disease is a major public health concern in Chile. Prior to the no operation after short-course radiotherapy followed by consolidation chemotherapy in locally advanced rectal cancer (NOAHS-ARC) trial, TNT-based treatments and W&W programs had not been implemented in Chile.

Methods/design: This single-arm, multicenter, phase II prospective trial, conducted in Santiago, Chile, will enroll patients with stage II/III rectal adenocarcinoma. Treatment involves induction short-course radiotherapy (25 Gy in 5 fractions) followed by consolidation chemotherapy (FOLFOX × 9 or CAPOX × 6 cycles). The response will be assessed 4-8 weeks after chemotherapy completion. Patients achieving cCR will be offered W&W, while those with incomplete responses will undergo total mesorectal excision. The primary endpoint is the rate of complete tumor response, combining pathologic complete responses (pCR) and sustained cCR (> 1 year), compared to a matched cohort treated with neoadjuvant chemoradiation alone. The trial aims to recruit 48 patients, assuming a combined pCR/sustained cCR rate of 12%. Quality of life measures will be assessed, and a biorepository of tissue and plasma samples will be established for future research, alongside serial endoscopic and MRI images.

Discussion: NOAHS-ARC seeks to advance organ preservation strategies in rectal cancer while pioneering TNT and W&W protocols in Chile. The study will also focus on functional outcomes and provide valuable data for improving patient care both locally and globally.

Trial registration: ClinicalTrials.gov identifier NCT04864067. Registered on April 28, 2021.

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局部晚期直肠癌（NOAHS-ARC）短程放疗后无需手术，再进行巩固化疗：前瞻性 II 期试验研究方案。

目的：通过观察和等待（W&W）策略保存器官已成为选择临床完全缓解（cCR）的直肠癌患者对总新辅助治疗（TNT）的可行选择。这种方法限制了与多模式治疗相关的发病率。然而，最佳治疗策略和治疗反应的预测因素仍未得到解决。直肠癌的发病率正在上升，特别是在发展中国家，这种疾病是智利一个主要的公共卫生问题。在局部晚期直肠癌短期放疗后巩固化疗后不手术（NOAHS-ARC）试验之前，智利尚未实施基于tnt的治疗和W&W计划。方法/设计：这项在智利圣地亚哥进行的单臂、多中心、II期前瞻性试验将招募II/III期直肠腺癌患者。治疗包括诱导短程放疗（5次25 Gy），然后是巩固化疗（FOLFOX × 9或CAPOX × 6周期）。化疗结束后4-8周评估疗效。达到cCR的患者将接受W&W治疗，而不完全缓解的患者将接受全肠系膜切除术。主要终点是肿瘤完全缓解率，结合病理完全缓解（pCR）和持续cCR（>1年），与单独接受新辅助放化疗的匹配队列相比。该试验旨在招募48名患者，假设pCR/持续cCR联合率为12%。将评估生活质量措施，并建立组织和血浆样本的生物储存库，用于未来的研究，以及一系列内窥镜和MRI图像。讨论：在智利开创TNT和W&W协议的同时，noaa - arc寻求在直肠癌中推进器官保存策略。该研究还将关注功能结果，并为改善当地和全球的患者护理提供有价值的数据。试验注册：ClinicalTrials.gov识别码NCT04864067。注册于2021年4月28日。

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来源期刊

International Journal of Colorectal Disease 医学-外科

CiteScore

4.90

自引率

3.60%

发文量

206

审稿时长

3-8 weeks

期刊介绍： The International Journal of Colorectal Disease, Clinical and Molecular Gastroenterology and Surgery aims to publish novel and state-of-the-art papers which deal with the physiology and pathophysiology of diseases involving the entire gastrointestinal tract. In addition to original research articles, the following categories will be included: reviews (usually commissioned but may also be submitted), case reports, letters to the editor, and protocols on clinical studies. The journal offers its readers an interdisciplinary forum for clinical science and molecular research related to gastrointestinal disease.