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

Phase 2

• Conditions: Colorectal Cancer
• Interventions: Procedure: laparoscopic surgery; Procedure: open surgery

• Registration Number: NCT00788281
• Lead Sponsor: Beijing Friendship Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Status Verified: 2008-11
• Study First Submitted: 2008-11-07
• Study First Submitted QC: 2008-11-07
• Study First Posted: 2008-11-10
• Last Update Submitted: 2008-11-12
• Last Update Posted: 2008-11-13
• Primary Completion: 2011-04
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	laparoscopic surgery	laparoscopic surgery plus postsurgery adjuvant chemotherapy of FOLFOX4
B	open surgery	open surgery plus postsurgery adjuvant chemotherapy of FOLFOX4

Primary Outcome Measures

Name	Time	Method
disease free survival rate	3 year
tumor residual rate of LRM and CRM	1 week
operation mortality	2 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Beijing Friendship Hospital, Department of General Surgery; 🇨🇳 Beijing, Beijing, China