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RECRUITING
NCT04370925
PHASE3

Efficacy of HIPEC in Patients With Colorectal Cancer at High Risk of Peritoneal Carcinomatosis

Sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the efficacy of adjuvant HIPEC with Mitomycin C after colectomy in the treatment of colorectal cancer patients at high risk of peritoneal carcinomatosis.

Official title: A Multicenter Prospective Randomized Controlled Clinical Trial of Hyperthermic Intraperitoneal Chemotherapy After Colectomy in Patients With Colorectal Cancer at High Risk of Peritoneal Carcinomatosis

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

688

Start Date

2020-06-04

Completion Date

2026-04-30

Last Updated

2020-06-16

Healthy Volunteers

No

Interventions

PROCEDURE

Radical colectomy

Patients undergo radical resection of the primary colorectal cancer(open or laparoscopic/robotic)

PROCEDURE

HIPEC

HIPEC(simultaneously or within 2days after resection) with mitomycin c (30 mg/m2) at 43°C for 90 minutes.

DRUG

Systemic chemotherapy

Systemic chemotherapy regimens: CapeOx and mFOLFOX6 are preferred for stage Ⅲ patients. CapeOx:oxaliplatin 130 mg/m2 IV d1 + capecitabine 1000mg/m2 po bid d1-14. Repeat every three weeks for eight cycles. mFOLFOX6:oxaliplatin 85 mg/m2 IV d1 + leucovorin calcium 400 mg/m2 IV d1 + 5-FU 400 mg/m2 IV bolus d1 + 5-FU 2400 mg/m2 continuous IV over 46-48 hours d1-2. Repeat every two weeks for twelve cycles. For stageⅡpatiens, regimens recommend by NCCN guide line(2019 v1) are acceptable.

Locations (37)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Beijing Hospital

Beijing, Beijing Municipality, China

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, China

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

The First People's Hospital of FoShan (Affiliated FoShan Hospital of Sun Yat-sen University)

Foshan, Guangdong, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Guangdong Provincal people's Hospital

Guangzhou, Guangdong, China

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Guangzhou, Guangdong, China

Guangdong Provincial Hospital of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

The Six Affiliated Hospital,Sun Yat-sen University

Guangzhou, Guangdong, China

JiangMen Central Hospital Affiliated JiangMen Hospital Of SUN YAT-SEN University

Jiangmen, Guangdong, China

MeiZhou People's Hospital

Meizhou, Guangdong, China

Affiliated Shantou Hospital of Sun Yat-sen University

Shantou, Guangdong, China

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

Zhongshan City People's Hospital

Zhongshan, Guangdong, China

Zhuhai People's Hospital, Zhuhai hospital affiliated with Jinan University

Zhuhai, Guangdong, China

People's hospital of guangxi zhuang autonomous region

Nanning, Guangxi, China

The Affiliated Tumor Hospital of Guangxi Medical University

Nanning, Guangxi, China

Hebei Medical University Fourth Hospital

Shijiazhuang, Hebei, China

Union Hospital,Tongji Medical College, Huazhong Uninersity of Science and Technolgy

Wuhan, Hubei, China

Wuhan University Renmin Hospital

Wuhan, Hubei, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

the First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

The Third Peoples' Hospital of Chengdu

Chengdu, Sichuan, China

West China Hospital,Sichuan University

Chengdu, Sichuan, China

People'S Hospital of Deyang City

Deyang, Sichuan, China

Leshan people's Hospital

Leshan, Sichuan, China

The Affiliated hospital of southwest medical university

Luzhou, Sichuan, China

The Second Affiliated Hospital,Zhejiang University School of Medicine

Hangzhou, Zhejiang, China