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

Last updated: June 15, 2020
Sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Overall Status: Active - Recruiting

Phase

3

Condition

Colon Cancer; Rectal Cancer

Colon Cancer

Colorectal Cancer

Treatment

N/A

Clinical Study ID

NCT04370925
HIPEC-06
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age between 18 and 70 years

  • Nonpregnant or breast-feeding women

  • ECOG status 0-1

  • Colorectal adenocarcinoma or mucinous adenocarcinoma;

  • Intraoperative confirmed cT4N0-2M0 Colorectal cancer (visual determination - accordingto AJCC 8th edition) without previous anti-cancer treatment and R0 resection could beachieved

  • Laboratory tests within 2 weeks before Randomization:Neutrophil ≥ 2.0 /mm3, ,platelets ≥ 100,000/mm3, hemoglobin≥90g/l, Alanine transaminase (ALT) and aspartateaminotransferase (AST) ≤ 2.5 ×ULN), total bilirubin(TBIL)≤ 1.5 × ULN, serum creatinine ≤ 1.5 ×ULN

  • Written informed consent

Exclusion

Exclusion Criteria:

  • Rectal cancer below peritoneal reflection

  • Concurrent with or have other cancer within the past 5 years ( except for skin basalcell carcinoma, or cervical carcinoma in situ, who have received radical treatment)

  • Severe abdominal infection or extensive fibrosis of peritoneal cavity that lead toimpossible separation

  • Surgical procedures conversion(from robotic or laparoscopic surgery to laparotomy) oremergency surgery due to perforation or obstruction

  • Existence of distance metastasis during surgery (M1) or can not achieve R0 resection

  • Contraindiction of mitomycin c(chickenpox or shingles)

  • Poorly controlled respiratory or cardiac disease, severe hepatic or renaldysfunction,drug abuse or uncontrolled mental disease

Study Design

Total Participants: 688
Study Start date:
June 04, 2020
Estimated Completion Date:
April 30, 2026

Study 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.

Connect with a study center

  • Beijing Hospital

    Beijing, Beijing
    China

    Site Not Available

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing
    China

    Site Not Available

  • Peking University Cancer Hospital & Institute

    Beijing, Beijing
    China

    Site Not Available

  • Peking University People's Hospital

    Beijing, Beijing 100044
    China

    Site Not Available

  • Chongqing Cancer Hospital

    Chongqing, Chongqing
    China

    Site Not Available

  • First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing
    China

    Site Not Available

  • Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing
    China

    Site Not Available

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

    Foshan, Guangdong
    China

    Site Not Available

  • Affiliated Cancer Hospital & Institute of Guangzhou Medical University

    Guangzhou, Guangdong 510095
    China

    Active - Recruiting

  • Guangdong Provincal people's Hospital

    Guangzhou, Guangdong 510080
    China

    Site Not Available

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

    Guangzhou, Guangdong 510120
    China

    Site Not Available

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong 510515
    China

    Site Not Available

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Site Not Available

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong
    China

    Site Not Available

  • The Six Affiliated Hospital,Sun Yat-sen University

    Guangzhou, Guangdong
    China

    Site Not Available

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

    Jiangmen, Guangdong
    China

    Site Not Available

  • MeiZhou People's Hospital

    Meizhou, Guangdong
    China

    Active - Recruiting

  • Affiliated Shantou Hospital of Sun Yat-sen University

    Shantou, Guangdong
    China

    Site Not Available

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong
    China

    Site Not Available

  • Zhongshan City People's Hospital

    Zhongshan, Guangdong
    China

    Site Not Available

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

    Zhuhai, Guangdong
    China

    Site Not Available

  • People's hospital of guangxi zhuang autonomous region

    Nanning, Guangxi Zhuang Autonomous Region
    China

    Site Not Available

  • The Affiliated Tumor Hospital of Guangxi Medical University

    Nanning, Guangxi Zhuang Autonomous Region
    China

    Site Not Available

  • Hebei Medical University Fourth Hospital

    Shijiazhuang, Hebei
    China

    Site Not Available

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

    Wuhan, Hubei 430030
    China

    Active - Recruiting

  • Wuhan University Renmin Hospital

    Wuhan, Hubei
    China

    Site Not Available

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei
    China

    Site Not Available

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu
    China

    Site Not Available

  • the First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai
    China

    Site Not Available

  • West China Hospital,Sichuan University

    Chendu, Sichuan
    China

    Site Not Available

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan 610072
    China

    Active - Recruiting

  • The Third Peoples' Hospital of Chengdu

    Chengdu, Sichuan
    China

    Site Not Available

  • People'S Hospital of Deyang City

    Deyang, Sichuan
    China

    Site Not Available

  • Leshan people's Hospital

    Leshan, Sichuan
    China

    Site Not Available

  • The Affiliated hospital of southwest medical university

    Luzhou, Sichuan
    China

    Site Not Available

  • The Second Affiliated Hospital,Zhejiang University School of Medicine

    Hangzhou, Zhejiang
    China

    Site Not Available

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