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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
119
Patients receive 5-Fu and oxaliplatin based neoadjuvant chemotherapy for 3 months
Patient receive total mesorectal excision after neoadjuvant chemotherapy
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGpathologic complete response rate
the number of patients with pCR divided by the total number of patients
Time frame: 30 days
3 year disease-free survival
cumulative rate of survival without cancer after 3 years follow up
Time frame: three years after the enrollment
surgical complication rate
rate of patients who had surgical complications during the perioperative period
Time frame: 30 days after the operation
Toxicity of neoadjuvant chemotherapy
category and grade of adverse event during neoadjuvant chemotherapy
Time frame: 4 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.