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,Clinical Colorectal Cancer

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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
Clinical Colorectal Cancer ( IF 3.4 ) Pub Date : 2023-06-11 , DOI: 10.1016/j.clcc.2023.06.002
Beatrice Borelli ₁ , Veronica Conca ₁ , Martina Carullo ₁ , Aldo Sainato ₂ , Roberto Mattioni ₂ , Bruno Manfredi ₂ , Riccardo Balestri ₃ , Piero Buccianti ₃ , Luca Morelli ₄ , Piercarlo Rossi ₅ , Paola Vagli ₅ , Alessandra Anna Prete ₆ , Frassineti Luca ₇ , Federica Morano ₈ , Samantha Di Donato ₉ , Lisa Salvatore ₁₀ , Carmelo Bengala ₁₁ , Daniele Rossini ₁ , Luca Boni ₁₂ , Carlotta Antoniotti ₁ , Chiara Cremolini ₁ , Gianluca Masi ₁ , Roberto Moretto ₁₃

Affiliation

Unit of Medical Oncology 2, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy; Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.
Radiation Oncology Unit, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.
General Surgery, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.
General Surgery, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.
Cisanello Radiology Unit, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.
Oncology Unit 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.
Medical Oncology Unit, IRST IRCCS, Meldola, Italy.
Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.
Department of Medical Oncology, Nuovo Ospedale di Prato Santo Stefano, Prato, Italy.
Oncologia Medica, Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy; Oncologia Medica, Università Cattolica del Sacro Cuore, Roma, Italy.
Medical Oncology Unit, Ospedale Misericordia, Grosseto, Italy.
Clinical Epidemiology Unit, IRCCS Ospedale Policlinico San Martino, Genova, Italy.
Unit of Medical Oncology 2, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.

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.

中文翻译：

ShorTrip 试验：一项前瞻性、多中心 II 期单臂试验，先进行短程放疗，然后采用三联 FOLFOXIRI 强化巩固化疗作为局部晚期直肠癌的总体新辅助治疗

背景

对于接受术前（化疗）放疗和手术治疗的局部晚期直肠癌（LARC）患者，辅助化疗的可行性较差，且其益处值得怀疑。在过去的几年里，人们对几种总新辅助治疗（TNT）策略进行了研究，将辅助化疗转移到新辅助治疗，目的是提高全身化疗的依从性，更早治疗微转移，然后减少远处复发。

患者和方法

ShorTrip (NTC05253846) 是一项前瞻性、多中心、单组 II 期试验，其中 63 名 LARC 患者将接受短程放疗，然后采用 FOLFOXIRI 方案强化巩固化疗和手术。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 第一个周期期间，3 至 4 级中性粒细胞减少症的发生率较高（N = 7，64%）。因此，该方案已进行修订，建议在巩固化疗的第一个周期中省略伊立替康。修订后，在随后的安全性分析中，重点关注前 9 名接受FOLFOX 作为第一个周期治疗，然后接受 FOLFOXIRI 治疗的患者，在第二个周期中仅报告了 1 例 3 至 4 级中性粒细胞减少症。