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

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.

Conditions

• Colorectal Cancer

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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University

  collaborator OTHER

• Sun Yat-sen University

  collaborator OTHER

• Sixth Affiliated Hospital, Sun Yat-sen University

  collaborator OTHER

• First Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Guangdong Provincial Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Guangdong Provincial People's Hospital

  collaborator OTHER

• Meizhou People's Hospital

  collaborator OTHER

• First People's Hospital of Foshan

  collaborator OTHER

• Shantou Central Hospital

  collaborator OTHER

• Jiangmen Central Hospital

  collaborator OTHER

• Shenzhen Second People's Hospital

  collaborator OTHER

• Zhongshan People's Hospital, Guangdong, China

  collaborator OTHER

• ZhuHai Hospital

  collaborator OTHER

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  collaborator OTHER

• Beijing Hospital

  collaborator OTHER_GOV

• Peking University Cancer Hospital & Institute

  collaborator OTHER

• Peking University People's Hospital

  collaborator OTHER

• Fudan University

  collaborator OTHER

• The Second Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• Chongqing University Cancer Hospital

  collaborator OTHER

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Renmin Hospital of Wuhan University

  collaborator OTHER

• Wuhan University

  collaborator OTHER

• Sichuan Provincial People's Hospital

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• The People's Hospital of Leshan

  collaborator OTHER

• People's Hospital of Deyang City

  collaborator UNKNOWN

• Hebei Medical University Fourth Hospital

  collaborator OTHER

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• The Affiliated Hospital Of Southwest Medical University

  collaborator OTHER

• The Affiliated Hospital of Xuzhou Medical University

  collaborator OTHER

• People's Hospital of Guangxi Zhuang Autonomous Region

  collaborator OTHER

• The Third People's Hospital of Chengdu

  collaborator OTHER

• The Affiliated Tumor Hospital of Guangxi Medical University

  collaborator UNKNOWN

• Affiliated Cancer Hospital & Institute of Guangzhou Medical University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-04

Primary Completion

2024-04-30

Completion

2026-04-30

Countries

• China

Study Locations