Overview

This trial is active, not recruiting.

Condition colorectal cancer
Treatments open surgery, laparoscopic surgery
Phase phase 3
Sponsor Cai Kailin
Collaborator Huazhong University of Science and Technology
Start date June 2014
End date June 2019
Trial size 1300 participants
Trial identifier NCT02248038, ChiCTR-TRC-14004767

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Conventional procedure
open surgery open
Patients in this arm undergo radical resection of colon cancer in open surgery.Open surgery is a conventional technique for colorectal cancer patients.
(Experimental)
Minimum invasive procedure
laparoscopic surgery laparoscopic
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 Outcomes

Measure
5 years diseases free survival rate
time frame: five years
5 years overall survival rate
time frame: five years

Eligibility Criteria

Male or female participants up to 80 years old.

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

Additional Information

Official title A Multicenter Randomized Clinical Trial on Laparoscopic Colorectal Cancer Surgery Compared With Open Surgery in China
Principal investigator Shi Wang, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Huazhong University of Science and Technology.