Rectal Cancer Clinical Trial
Official title:
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
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.
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.
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