局部进展期胰腺癌新辅助治疗中应用立体定向体部放疗和术中放疗联合初始化疗的Ⅱ期临床试验方案

A phase II trial proposal of total neoadjuvant treatment with primary chemotherapy, stereotactic body radiation therapy, and intraoperative radiation therapy in borderline resectable pancreatic adenocarcinoma.

机构信息

Unit of General and Pancreatic Surgery, University of Verona Hospital Trust, Policlinico Rossi, Piazzale L.A. Scuro 10, 37134, Verona, Italy.

Unit of Radiation Oncology, University of Verona Hospital Trust, Verona, Italy.

出版信息

BMC Cancer. 2021 Feb 16;21(1):165. doi: 10.1186/s12885-021-07877-7.

DOI:10.1186/s12885-021-07877-7

PMID:33593311

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7885611/

Abstract

BACKGROUND

The current management guidelines recommend that patients with borderline resectable pancreatic adenocarcinoma (BRPC) should initially receive neoadjuvant chemotherapy. The addition of advanced radiation therapy modalities, including stereotactic body radiation therapy (SBRT) and intraoperative radiation therapy (IORT), could result in a more effective neoadjuvant strategy, with higher rates of margin-free resections and improved survival outcomes.

METHODS/DESIGN: In this single-center, single-arm, intention-to-treat, phase II trial newly diagnosed BRPC will receive a "total neoadjuvant" therapy with FOLFIRINOX (5-fluorouracil, irinotecan and oxaliplatin) and hypofractionated SBRT (5 fractions, total dose of 30 Gy with simultaneous integrated boost of 50 Gy on tumor-vessel interface). Following surgical exploration or resection, IORT will be also delivered (10 Gy). The primary endpoint is 3-year survival. Secondary endpoints include completion of neoadjuvant treatment, resection rate, acute and late toxicities, and progression-free survival. In the subset of patients undergoing resection, per-protocol analysis of disease-free and disease-specific survival will be performed. The estimated sample size is 100 patients over a 36-month period. The trial is currently recruiting.

TRIAL REGISTRATION

NCT04090463 at clinicaltrials.gov.

摘要

背景

目前的治疗指南建议，交界可切除的胰腺腺癌（BRPC）患者应首先接受新辅助化疗。先进的放射治疗技术的加入，包括立体定向体部放射治疗（SBRT）和术中放射治疗（IORT），可能会导致更有效的新辅助策略，无边缘切除率更高，生存结果得到改善。

方法/设计：在这项单中心、单臂、意向治疗、II 期试验中，新诊断的 BRPC 将接受 FOLFIRINOX（氟尿嘧啶、伊立替康和奥沙利铂）和低分割 SBRT（5 个疗程，总剂量 30Gy，同时在肿瘤血管界面进行 50Gy 的同步整合boost）的“完全新辅助”治疗。在手术探查或切除后，还将进行 IORT（10Gy）。主要终点是 3 年生存率。次要终点包括新辅助治疗完成率、切除率、急性和迟发性毒性以及无进展生存期。在接受切除术的患者亚组中，将进行无病和疾病特异性生存的方案分析。预计在 36 个月的时间内招募 100 名患者。该试验正在进行中。