Clinical trial NCT00788281: A Multi-Center Randomised Controlled Study to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Colorectal Cancer
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2008-11-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: disease free survival rate
timeFrame: 3 year
measure: tumor residual rate of LRM and CRM
timeFrame: 1 week
measure: operation mortality
timeFrame: 2 months
Secondary outcomes:
measure: survival rate
timeFrame: 3 year
measure: survival rate
timeFrame: 5 year
measure: local recurrence rate
timeFrame: 5 year
measure: operation time
timeFrame: at the end of operation
measure: blood lost
timeFrame: during operation
measure: analgesic dosage
timeFrame: 1,2 and 3 days post surgery
measure: evacuating time
timeFrame: post surgery
measure: operation morbidity
timeFrame: 2 months
measure: transfer to open surgery
timeFrame: during operation
measure: fee
timeFrame: peri-operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Department of General Surgery
state: Beijing
Study officials:
affiliation: beijing friendship hospital, department of general surgery
name: zhongtao zhang, doctor
role: PRINCIPAL_INVESTIGATOR
References: