Status:
UNKNOWN
A Multi-Center Randomised Controlled Study to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer
Lead Sponsor:
Beijing Friendship Hospital
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 unkn...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2016
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00788281
Start Date
April 1 2008
End Date
April 1 2016
Last Update
November 13 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Friendship Hospital, Department of General Surgery
Beijing, Beijing Municipality, China, 100050