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

Study Overview
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Brief Summary
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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.

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Procedure: laparoscopic surgery
* Procedure: open surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |