Spots Global Cancer Trial Database for Efficacy of HIPEC in Patients With Colorectal Cancer at High Risk of Peritoneal Carcinomatosis
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Trial Identification
Brief Title: Efficacy of HIPEC in Patients With Colorectal Cancer 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
Study ID: NCT04370925
Conditions
Study Description
Brief 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.
Detailed Description: The effectiveness of cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC) have been addressed for the treatment of peritoneal carcinomatosis in selected patients. However, prophylactic HIPEC in colorectal cancer patients at high risk of metachronous peritoneal metastases remained controversial. In this study, patients with colorectal cancer cT4N0-2M0(AJCC/UICC staging system 8th edition) and planed to undergo intentionally colectomy (laparotomy, laparoscopy，or robotic ) are randomized into HIPEC group and control group. In HIPEC group, closed HIPEC is performed with Mitomycin C(30mg/m2) at 43 °C for 90 minutes, simultaneously or within 2 days after colectomy and followed by systemic chemotherapy. For the patients in the control group, systemic chemotherapy were administered after colectomy. The primary endpoint is peritoneal recurrence-free survival (pRFS) rate. Secondary end points include overall survival (OS) rate, disease free survival (DFS) rate, liver metastatic rate, toxic effects, quality of life scores. All efficacy analyses are conducted in the intention-to-treat population, per-protocol population and pT4 subgroups due to pathologic tumor invasion can not be acquired before HIPEC. Safety analysis include only patients who receive their randomly assigned treatment.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Peking University People's Hospital, Beijing, Beijing, China
Beijing Hospital, Beijing, Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing, China
Peking University Cancer Hospital & Institute, Beijing, Beijing, China
Chongqing Cancer Hospital, Chongqing, Chongqing, China
First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, China
Second Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, 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 Zhuang Autonomous Region, China
The Affiliated Tumor Hospital of Guangxi Medical University, Nanning, Guangxi Zhuang Autonomous Region, 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, China
West China Hospital，Sichuan University, Chendu, Sichuan, China
Sichuan Provincial People's Hospital, Chengdu, Sichuan, China
The Third Peoples' Hospital of Chengdu, 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
Contact Details
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