Total neoadjuvant treatment with long-course radiotherapy versus concurrent chemoradiotherapy in local advanced rectal cancer with high risk factors (TNTCRT): A multicenter, randomized, open-label, phase 3 trial.

作者：X. Wang, Ping Liu, Yi Xiao, Wenjian Meng, Yuanling Tang, Jitao Zhou, Pei-Rong Ding, Kefeng Ding, Biao Wang, Qing Guo, Hao Sun, Jian Qiu, Yongyang Yu, Bing Wu, Hanjiang Zeng, Xiangbing Deng, Dan Jiang, Yali Shen, Zong‐Guang Zhou, Ziqiang Wang · 发表于：Journal of Clinical Oncology · 年份：2024 · DOI：10.1200/jco.2024.42.17_suppl.lba3511 · 被引用次数：17 · 研究领域：Colorectal Cancer Surgical Treatments、Colorectal and Anal Carcinomas、Colorectal Cancer Treatments and Studies

LBA3511 Background: Distant metastases remain a common problem in locally advanced rectal cancer (LARC) patients who received neoadjuvant chemoradiotherapy (NCRT) and surgery. Previous researchers have demonstrated the survival benefits of total neoadjuvant treatment (TNT) using short-course radiotherapy with CAPOX and long-course radiotherapy (LCRT) with mFOLFIRINOX. This study aimed to explore the efficacy of TNT using long-course radiotherapy (LCRT) combined with CAPOX. Methods: In this phase 3, open-label, multicenter, randomized trial, eligible pts were diagnosed as stage II/III and had at least one high risk factor: cT4a-b (resectable), cT3c-d with extramural venous invasion, cN2; involved mesorectal fascia, or enlarged lateral lymph nodes. Pts were randomly assigned to either Arm A to receive TNT (LCRT with six cycles of neoadjuvant CAPOX (one cycle of induction CAPOX, two cycles of concurrent CAPOX, and three cycles of consolidation CAPOX) followed by total mesorectal excision (TME)) or Arm B to receive NCRT (LCRT with concomitant capecitabine, followed by TME and adjuvant CAPOX). Radiotherapy in both groups was administered at 50-50.4 Gy in 25-28 fractions. The primary endpoint was disease free survival (DFS). The secondary endpoints were pathological response complete (pCR) rate, overall survival (OS), metastasis-free survival (MFS) and postoperative 30-day morbidity. Results: (ITT) Between June 6, 2017, and Mar 5, 2024, 458 pts were randomly assigned to two Arms (2...