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

September 23, 2014 updated by: Cai Kailin

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

1300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Union Hospital, Huazhong University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: open surgery
Conventional procedure
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.
Other Names:
  • open
EXPERIMENTAL: laparoscopic surgery
Minimum invasive procedure
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.
Other Names:
  • laparoscopic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
5 years diseases free survival rate
Time Frame: five years
five years
5 years overall survival rate
Time Frame: five years
five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cai Kailin

Collaborators

Peking Union Medical College Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
Huazhong University of Science and Technology
Nanfang Hospital of Southern Medical University

Investigators

  • Study Director: Kailin Cai, MD,PhD, Wuhan Union Hospital, China
  • Principal Investigator: Shi Wang, MD, Wuhan Union Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (ANTICIPATED)

June 1, 2019

Study Completion (ANTICIPATED)

June 1, 2019

Study Registration Dates

First Submitted

September 9, 2014

First Submitted That Met QC Criteria

September 23, 2014

First Posted (ESTIMATE)

September 25, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

September 25, 2014

Last Update Submitted That Met QC Criteria

September 23, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChiCTR-TRC-14004767 (REGISTRY: ChiCTR-TRC-14004767)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe