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Clinical Trial Summary

This study is designed to test the Safety and efficacy of induction and individualized neoadjuvant chemotherapy based on oxaliplatin combined with fluorouracil for MRF-negative, moderate-risk and initially resectable middle and low rectal cancer.


Clinical Trial Description

Preoperative chemoradiation has become standard treatment for stage 2/3 rectal cancer. But for moderate-risk rectal cancer patients, whether neoadjuvant chemotherapy followed with total mesorectal excision is adequate for local control is still unknown. The necessity of preoperative radiotherapy for these patients needs further exploration.

This study is a single-arm, single-center, prospective, phase II clinical study. It is designed to test the efficacy and safety of neoadjuvant chemotherapy for MRF-negative, moderate-risk and initially resectable middle and low rectal cancer.

In this study, patients with MRI defined moderate-risk rectal cancer will receive a three-month neoadjuvant chemotherapy based on Oxaliplatin combined with Fluorouracil(CapeOX,SOX,mFOLFOX6,etc.) and Total mesorectal excision.

Primary Endpoint is pCR rate.Secondary endpoint concludes toxic reactions of neoadjuvant chemotherapy, Incidence of surgical complications and three-year disease-free survival (DFS).

This study is designed to recruit 119 patients in all. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04296240
Study type Interventional
Source Beijing Cancer Hospital
Contact Xinyu Wang
Phone +8618511834100
Email wxy_196@163.com
Status Recruiting
Phase Phase 2
Start date March 1, 2019
Completion date April 2024

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