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

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: Colorectal Cancer
• Intervention / Treatment: Procedure: laparoscopic surgery; Procedure: open surgery

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2

Contacts and Locations

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

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

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	3 year
tumor residual rate of LRM and CRM	1 week
operation mortality	2 months

Secondary Outcome Measures

Outcome Measure	Time Frame
survival rate	3 year
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

Collaborators and Investigators

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

Study record dates

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: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: BJLS01