Randomized Trial of Primary Surgery Followed Selective Radiochemotherapy for Rectal Cancer With MRI Negative CRM

Phase 3 Suspended 350 enrolled Zhejiang University

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine whether primary radiotherapy can be omitted for the locally advanced rectal cancer with Magnetic Resonance Imaging (MRI) negative circumferential margin.

Timeline

Start: 2015-10
Primary completion: 2024-02
Completion: 2026-02

Outcome

Outcome not reported

Stopped: “DSMB stopped this trial due to the difference of 3-year DFS's rate between two groups more than 5% at the interim analysis in July 2021.”

Publications

Li M, Sun H, Yang W, Luo J, Lin H, Zhou T, Gong H, Zhao D, Niu Z, Wang Z, Liu B, Yi Y, Huang W, Li B. A Phase 1b Clinical Trial of Neoadjuvant Radio-immunotherapy for Esophageal Squamous Cell Cancer. Int J Radiat Oncol Biol Phys. 2024 Jul 1;119(3):896-901. doi: 10.1016/j.ijrobp.2023.12.033. Epub 2024 Jan 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Capecitabine	Small molecule	825 mg/m2	—
Subject	Capecitabine	Small molecule	1000 mg/m2	—
Subject	Capecitabine	Small molecule	1250 mg/m2	—
Subject	Oxaliplatin	Small molecule	130 mg/m2	—