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

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
laparoscopic surgery
open surgery
Sponsored by
Beijing Friendship Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Friendship Hospital, Department of General SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

laparoscopic surgery plus postsurgery adjuvant chemotherapy of FOLFOX4

open surgery plus postsurgery adjuvant chemotherapy of FOLFOX4

Outcomes

Primary Outcome Measures

disease free survival rate
tumor residual rate of LRM and CRM
operation mortality

Secondary Outcome Measures

survival rate
survival rate
local recurrence rate
operation time
blood lost
analgesic dosage
evacuating time
operation morbidity
transfer to open surgery
fee

Full Information

First Posted
November 7, 2008
Last Updated
November 12, 2008
Sponsor
Beijing Friendship Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00788281
Brief Title
A Multi-Center Randomised Controlled Study to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Unknown status
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
April 2016 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Beijing Friendship Hospital

4. Oversight

5. Study Description

Brief Summary
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.

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 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
laparoscopic surgery plus postsurgery adjuvant chemotherapy of FOLFOX4
Arm Title
B
Arm Type
Active Comparator
Arm Description
open surgery plus postsurgery adjuvant chemotherapy of FOLFOX4
Intervention Type
Procedure
Intervention Name(s)
laparoscopic surgery
Intervention Description
surgery would be performed by laparoscope
Intervention Type
Procedure
Intervention Name(s)
open surgery
Intervention Description
surgery would be performed by traditional surgery.
Primary Outcome Measure Information:
Title
disease free survival rate
Time Frame
3 year
Title
tumor residual rate of LRM and CRM
Time Frame
1 week
Title
operation mortality
Time Frame
2 months
Secondary Outcome Measure Information:
Title
survival rate
Time Frame
3 year
Title
survival rate
Time Frame
5 year
Title
local recurrence rate
Time Frame
5 year
Title
operation time
Time Frame
at the end of operation
Title
blood lost
Time Frame
during operation
Title
analgesic dosage
Time Frame
1,2 and 3 days post surgery
Title
evacuating time
Time Frame
post surgery
Title
operation morbidity
Time Frame
2 months
Title
transfer to open surgery
Time Frame
during operation
Title
fee
Time Frame
peri-operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jin wang, doctor
Phone
86-10-63138712
Email
zhangzht@medmail.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
xiaotian zhang, doctor
Phone
86-10-88196561
Email
zhangxtxx@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zhongtao zhang, doctor
Organizational Affiliation
beijing friendship hospital, department of general surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Friendship Hospital, Department of General Surgery
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhongtao zhang, doctor
First Name & Middle Initial & Last Name & Degree
zhongtao zhang, doctor

12. IPD Sharing Statement

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

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