Neoplasms

Digestive System Diseases

All Conditions

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Antiemetics

Gastrointestinal Agents

Capecitabine

Fluorouracil

Oxaliplatin

Antimetabolites

Oxaliplatin 130mg/m2 d1 and Capecitabine 1250mg/m2 bid1-14 or other fluorouracils, every 21 or 14 days for 2 to 4 cycles, and efficacy evaluation every 2 cycles;

Patients receive 5-Fu and oxaliplatin based neoadjuvant chemotherapy for 3 months

Oxaliplatin and capecitabine

Patient receive total mesorectal excision after neoadjuvant chemotherapy

Total Mesorectal Excision

Xinyu Wang

Aiwen Wu, MD

Aiwen Wu

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.

Induction Chemotherapy for MRF-negative, Moderate-risk, Resectable Middle and Low Rectal Cancer

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

the number of patients with pCR divided by the total number of patients

cumulative rate of survival without cancer after 3 years follow up

rate of patients who had surgical complications during the perioperative period

category and grade of adverse event during neoadjuvant chemotherapy

Peking University Cancer Hospital & Institute

chief, Unit III & Ostomy Service, Gastrointestinal Cancer

Rare Diseases

Stomach Neoplasms

Stomach Diseases

Stomach Cancer

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Capecitabine: 1000mg/m\^2 bid, days 1-14, every 3 weeks until progression/intolerance.

Before randomization,all enrolled patients underwent 3 cycles XELOX chemotheray. After patients' disease achieved CR\\PR\\SD,then randomized into this clinical trial.

Oxaliplatin and Capecitabine

Chengya Zhou, bachelor

To confirm the efficacy and safety of XELOX with capecitabine maintenance in treatment of advanced gastric cancer (AGC)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Induction Chemotherapy for MRF-negative, Moderate-risk, Resectable Middle and Low Rectal Cancer	NCT04296240	Rectal Cancer	Oxaliplatin and... Total Mesorecta...	18 Years - 80 Years	Peking University Cancer Hospital & Institute
Induction Chemotherapy for MRF-negative, Moderate-risk, Resectable Middle and Low Rectal Cancer	NCT04296240	Rectal Cancer	Oxaliplatin and... Total Mesorecta...	18 Years - 80 Years	Peking University Cancer Hospital & Institute
Induction Chemotherapy for MRF-negative, Moderate-risk, Resectable Middle and Low Rectal Cancer	NCT04296240	Rectal Cancer	Oxaliplatin and... Total Mesorecta...	18 Years - 80 Years	Peking University Cancer Hospital & Institute
The Maintenance Therapy of Capecitabine of Advanced Gastric Cancer	NCT02038621	Advanced Gastri...	Paclitaxel Oxaliplatin and...	18 Years -	The Second People's Hospital of Sichuan

Spots Global Cancer Trial Database for oxaliplatin and capecitabine