A Multi-Center Randomised Controlled Study to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer

November 12, 2008 updated by: Beijing Friendship Hospital
Laparoscopic surgery has been widely accepted for its minimal invasion and safety. However, whether it has the same survival benefit as the traditional open surgery in Chinese population is still unknown. So we designed this study to evaluate the 3 year disease free survival rate in the laparoscopic group versus the open surgery group.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2

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
    • Beijing
      • Beijing, Beijing, China, 100050
        • Recruiting
        • Beijing Friendship Hospital, Department of General Surgery
        • Contact:
          • zhongtao zhang, doctor
        • Principal Investigator:
          • zhongtao zhang, doctor

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed consent
  • Pathologically confirmed adenocarcinoma
  • Pre-surgery image staging as (CT/MRI):T2-3,N0-2,M0,(TNM stage，AJCC，version of 2003)
  • Single tumor locating at cecum, ascending colon, descending colon, sigmoid colon, rectosigmoid junction, rectum(distance from anal verge more than 7cm)
  • Tumor diameter less than 6cm
  • Age 18-75 year
  • ECOG 0-2
  • Predicted survival longer than 6 months
  • Normal liver, renal, bone marrow function: (GPT less than 2 ULN，total bilirubin less than 1.5mg/dl，Cr less than 1.5 ULN，WBC more than 4×109/L，PLT more than 100×109/L)
  • No previous history of gastrointestinal surgery
  • No previous history of chemotherapy or radiotherapy

Exclusion criteria

  • Severe and uncontrolled medical disease including unstable angina pectoris, cardiac infarction and cerebral attack in 6 months
  • Could not tolerant general anesthesia or surgery for other organ dis-function
  • Allergy to chemotherapeutical agents in the protocol
  • History of other malignant tumor within 5 years
  • Severe mental disorder
  • Continued systematic steroid therapy
  • Woman during pregnancy or lactation
  • Under study of other clinical trial
  • No compliance of the protocol
  • Discovery of distant metastasis during surgery
  • Postsurgery stage of I or IV tumors

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
laparoscopic surgery plus postsurgery adjuvant chemotherapy of FOLFOX4
Procedure: laparoscopic surgery
surgery would be performed by laparoscope
Active Comparator: B
open surgery plus postsurgery adjuvant chemotherapy of FOLFOX4
Procedure: open surgery
surgery would be performed by traditional surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
disease free survival rate
Time Frame: 3 year
3 year
tumor residual rate of LRM and CRM
Time Frame: 1 week
1 week
operation mortality
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
survival rate
Time Frame: 3 year
3 year
survival rate
Time Frame: 5 year
5 year
local recurrence rate
Time Frame: 5 year
5 year
operation time
Time Frame: at the end of operation
at the end of operation
blood lost
Time Frame: during operation
during operation
analgesic dosage
Time Frame: 1,2 and 3 days post surgery
1,2 and 3 days post surgery
evacuating time
Time Frame: post surgery
post surgery
operation morbidity
Time Frame: 2 months
2 months
transfer to open surgery
Time Frame: during operation
during operation
fee
Time Frame: peri-operation
peri-operation

Collaborators and Investigators

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

Sponsor

Beijing Friendship Hospital

Investigators

  • Principal Investigator: zhongtao zhang, doctor, Beijing Friendship Hospital, Department of General Surgery

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

April 1, 2008

Primary Completion (Anticipated)

April 1, 2011

Study Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

November 7, 2008

First Submitted That Met QC Criteria

November 7, 2008

First Posted (Estimate)

November 10, 2008

Study Record Updates

Last Update Posted (Estimate)

November 13, 2008

Last Update Submitted That Met QC Criteria

November 12, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BJLS01

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.

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