A Multicenter Clinical Trial on Laparoscopic Colorectal Cancer Surgery Compared With Open Surgery

Overview

The purpose of this study is to verify the 5-year disease free survival (DFS) of resectable colorectal cancer after laparoscopic surgery according to a Chinese Operative Standard was not inferior to open surgery.

Full Title of Study: “A Multicenter Randomized Clinical Trial on Laparoscopic Colorectal Cancer Surgery Compared With Open Surgery in China”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2019

Detailed Description

Study type:Interventional Study phase:Phase III Objectives of Study:to verify the 5-year DFS of resectable colorectal cancer after laparoscopic surgery according to a Chinese Operative Standard was not inferior to open surgery. Study design:Randomized parallel control

Interventions

  • Procedure: open surgery
    • Patients in this arm undergo radical resection of colon cancer in open surgery.Open surgery is a conventional technique for colorectal cancer patients.
  • Procedure: laparoscopic surgery
    • Patients in this arm undergo radical resection of colon cancer in laparoscopic surgery.Laparoscopic surgery is a new and minimum invasive technique for colorectal cancer patients.

Arms, Groups and Cohorts

  • Active Comparator: open surgery
    • Conventional procedure
  • Experimental: laparoscopic surgery
    • Minimum invasive procedure

Clinical Trial Outcome Measures

Primary Measures

  • 5 years diseases free survival rate
    • Time Frame: five years
  • 5 years overall survival rate
    • Time Frame: five years

Participating in This Clinical Trial

Inclusion Criteria

1. informed consent 2. single colorectal adenocarcinoma, located at any segment of the colorectum with lower margin 5cm or more to the dental line 3. cTNM:colon cancer T1-4N1-2M0,rectal cancer T1-3N1-2M0,longest diameter no more than 6cm 4. age less than 80 years old 5. normal blood routine test and hepatic or renal function test 6. no gastrointestinal surgery history or chemotherapy, radiation, No complete obstruction. Exclusion Criteria:

1. severe comorbidity such as heart attack or stroke, malignance in 5 years 2. can not tolerate to general anesthesia, pneumoperitoneum or surgery 3. pregnant or during breast-feeding period 4. attending other clinical trial involving therapy 5. cannot or disagree to attending the clinical trial

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cai Kailin
  • Collaborator
    • Huazhong University of Science and Technology
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Cai Kailin, Associate chief physician of gastrointestinal surgery – Huazhong University of Science and Technology
  • Overall Official(s)
    • Guobin Wang, MD,PhD, Study Chair, Wuhan Union Hospital, China
    • Kaixiong Tao, MD,PhD, Study Director, Wuhan Union Hospital, China
    • Kailin Cai, MD,PhD, Study Director, Wuhan Union Hospital, China
    • Shi Wang, MD, Principal Investigator, Wuhan Union Hospital, China

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