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

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
open surgery
laparoscopic surgery
Sponsored by
Cai Kailin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

undefined - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Union Hospital, Huazhong University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

open surgery

laparoscopic surgery

Arm Description

Conventional procedure

Minimum invasive procedure

Outcomes

Primary Outcome Measures

5 years diseases free survival rate
5 years overall survival rate

Secondary Outcome Measures

Full Information

First Posted
September 9, 2014
Last Updated
September 23, 2014
Sponsor
Cai Kailin
Collaborators
Huazhong University of Science and Technology, Nanfang Hospital, Southern Medical University, Second Affiliated Hospital, School of Medicine, Zhejiang University, Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02248038
Brief Title
A Multicenter Clinical Trial on Laparoscopic Colorectal Cancer Surgery Compared With Open Surgery
Official Title
A Multicenter Randomized Clinical Trial on Laparoscopic Colorectal Cancer Surgery Compared With Open Surgery in China
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Cai Kailin
Collaborators
Huazhong University of Science and Technology, Nanfang Hospital, Southern Medical University, Second Affiliated Hospital, School of Medicine, Zhejiang University, Peking Union Medical College Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
open surgery
Arm Type
Active Comparator
Arm Description
Conventional procedure
Arm Title
laparoscopic surgery
Arm Type
Experimental
Arm Description
Minimum invasive procedure
Intervention Type
Procedure
Intervention Name(s)
open surgery
Other Intervention Name(s)
open
Intervention Description
Patients in this arm undergo radical resection of colon cancer in open surgery.Open surgery is a conventional technique for colorectal cancer patients.
Intervention Type
Procedure
Intervention Name(s)
laparoscopic surgery
Other Intervention Name(s)
laparoscopic
Intervention Description
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.
Primary Outcome Measure Information:
Title
5 years diseases free survival rate
Time Frame
five years
Title
5 years overall survival rate
Time Frame
five years

10. Eligibility

Sex
All
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: informed consent single colorectal adenocarcinoma, located at any segment of the colorectum with lower margin 5cm or more to the dental line cTNM：colon cancer T1-4N1-2M0，rectal cancer T1-3N1-2M0，longest diameter no more than 6cm age less than 80 years old normal blood routine test and hepatic or renal function test no gastrointestinal surgery history or chemotherapy, radiation, No complete obstruction. Exclusion Criteria: severe comorbidity such as heart attack or stroke, malignance in 5 years can not tolerate to general anesthesia, pneumoperitoneum or surgery pregnant or during breast-feeding period attending other clinical trial involving therapy cannot or disagree to attending the clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guobin Wang, MD,PhD
Organizational Affiliation
Wuhan Union Hospital, China
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kaixiong Tao, MD,PhD
Organizational Affiliation
Wuhan Union Hospital, China
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kailin Cai, MD,PhD
Organizational Affiliation
Wuhan Union Hospital, China
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Shi Wang, MD
Organizational Affiliation
Wuhan Union Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Union Hospital, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China

12. IPD Sharing Statement

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

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