ShorTrip Trial: A Prospective, Multicentric Phase II Single-Arm Trial of Short-Course Radiotherapy Followed by Intensified Consolidation Chemotherapy With the Triplet FOLFOXIRI as Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer

IF 4.3 3区材料科学 Q1 ENGINEERING, ELECTRICAL & ELECTRONIC

ACS Applied Electronic Materials Pub Date : 2023-09-01 DOI:10.1016/j.clcc.2023.06.002

Beatrice Borelli , Veronica Conca , Martina Carullo , Aldo Sainato , Roberto Mattioni , Bruno Manfredi , Riccardo Balestri , Piero Buccianti , Luca Morelli , Piercarlo Rossi , Paola Vagli , Alessandra Anna Prete , Frassineti Luca , Federica Morano , Samantha Di Donato , Lisa Salvatore , Carmelo Bengala , Daniele Rossini , Luca Boni , Carlotta Antoniotti , Roberto Moretto

{"title":"ShorTrip Trial: A Prospective, Multicentric Phase II Single-Arm Trial of Short-Course Radiotherapy Followed by Intensified Consolidation Chemotherapy With the Triplet FOLFOXIRI as Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer","authors":"Beatrice Borelli , Veronica Conca , Martina Carullo , Aldo Sainato , Roberto Mattioni , Bruno Manfredi , Riccardo Balestri , Piero Buccianti , Luca Morelli , Piercarlo Rossi , Paola Vagli , Alessandra Anna Prete , Frassineti Luca , Federica Morano , Samantha Di Donato , Lisa Salvatore , Carmelo Bengala , Daniele Rossini , Luca Boni , Carlotta Antoniotti , Roberto Moretto","doi":"10.1016/j.clcc.2023.06.002","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>In patients with locally advanced rectal cancer (LARC) treated with preoperative (chemo) radiotherapy and surgery, adjuvant chemotherapy is poorly feasible and its benefit is questionable. In the last years, several total neoadjuvant treatment (TNT) strategies, moving the adjuvant chemotherapy to the neoadjuvant setting, have been investigated with the aim of improving compliance to systemic chemotherapy, treating micrometastases earlier and then reducing distant recurrence.</p></div><div><h3>Patients and Methods</h3><p>ShorTrip (NTC05253846) is a prospective, multicentre, single-arm phase II trial where 63 patients with LARC will be treated with short-course radiotherapy followed by intensified consolidation chemotherapy with FOLFOXIRI regimen and surgery. Primary endpoint is pCR. Among the first 11 patients who started consolidation chemotherapy, a preliminary safety analysis showed a high rate of grade 3 to 4 neutropenia (N = 7, 64%) during the first cycle of FOLFOXIRI. Therefore, the protocol has been emended with the recommendation to omit irinotecan during the first cycle of consolidation chemotherapy. After amendment, in a subsequent safety analysis focused on the first 9 patients treated with FOLFOX as first cycle and then with FOLFOXIRI, grade 3 to 4 neutropenia was reported in only one case during the second cycle.</p></div><div><h3>Aim of the study</h3><p>The aim of this study is to assess the safety and activity of a TNT strategy including SCRT, intensified consolidation treatment with FOLFOXIRI and delayed surgery. After protocol amendment, the treatment seems feasible without safety concern. Results are expected at the end of 2024.</p></div>","PeriodicalId":3,"journal":{"name":"ACS Applied Electronic Materials","volume":null,"pages":null},"PeriodicalIF":4.3000,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"ACS Applied Electronic Materials","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1533002823000592","RegionNum":3,"RegionCategory":"材料科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ENGINEERING, ELECTRICAL & ELECTRONIC","Score":null,"Total":0}

引用次数: 0

Abstract

Background

In patients with locally advanced rectal cancer (LARC) treated with preoperative (chemo) radiotherapy and surgery, adjuvant chemotherapy is poorly feasible and its benefit is questionable. In the last years, several total neoadjuvant treatment (TNT) strategies, moving the adjuvant chemotherapy to the neoadjuvant setting, have been investigated with the aim of improving compliance to systemic chemotherapy, treating micrometastases earlier and then reducing distant recurrence.

Patients and Methods

ShorTrip (NTC05253846) is a prospective, multicentre, single-arm phase II trial where 63 patients with LARC will be treated with short-course radiotherapy followed by intensified consolidation chemotherapy with FOLFOXIRI regimen and surgery. Primary endpoint is pCR. Among the first 11 patients who started consolidation chemotherapy, a preliminary safety analysis showed a high rate of grade 3 to 4 neutropenia (N = 7, 64%) during the first cycle of FOLFOXIRI. Therefore, the protocol has been emended with the recommendation to omit irinotecan during the first cycle of consolidation chemotherapy. After amendment, in a subsequent safety analysis focused on the first 9 patients treated with FOLFOX as first cycle and then with FOLFOXIRI, grade 3 to 4 neutropenia was reported in only one case during the second cycle.

Aim of the study

The aim of this study is to assess the safety and activity of a TNT strategy including SCRT, intensified consolidation treatment with FOLFOXIRI and delayed surgery. After protocol amendment, the treatment seems feasible without safety concern. Results are expected at the end of 2024.

查看原文本刊更多论文

ShorTrip试验：一项前瞻性的、多中心的II期单臂试验，即局部晚期癌症的短程放射治疗，然后用Triplet FOLFOXIRI作为全新辅助疗法强化巩固化疗

背景在局部晚期癌症（LARC）患者术前（化疗）放疗和手术治疗中，辅助化疗的可行性较差，其疗效值得怀疑。在过去的几年里，已经研究了几种完全新辅助治疗（TNT）策略，将辅助化疗转移到新辅助环境中，目的是提高对全身化疗的依从性，更早地治疗微转移，然后减少远处复发。患者和方法ShorTrip（NTC05253846）是一项前瞻性、多中心、单臂II期试验，63名LARC患者将接受短期放疗，然后采用FOLFOXIRI方案和手术进行强化巩固化疗。主要终点是pCR。在开始巩固化疗的前11名患者中，初步安全性分析显示，在FOLFOXIRI的第一个周期中，3至4级中性粒细胞减少症的发生率很高（N=7,64%）。因此，对方案进行了修订，建议在第一个周期的巩固化疗中省略伊立替康。修正后，在随后的安全性分析中，重点关注第一个周期接受FOLFOX治疗的前9名患者，然后接受FOLFOXIRI治疗，在第二个周期中，只有一例报告了3至4级中性粒细胞减少症。本研究的目的本研究的目标是评估TNT策略的安全性和活性，包括SCRT、FOLFOXIRI强化巩固治疗和延迟手术。方案修改后，在没有安全问题的情况下，这种治疗似乎是可行的。结果预计将在2024年底公布。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

ACS Applied Electronic Materials Multiple-

CiteScore

7.20

自引率

4.30%

发文量

567