A Multi-Center Randomised Controlled Study to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer
NCT ID: NCT00788281
Last Updated: 2008-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
200 participants
INTERVENTIONAL
2008-04-30
2016-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A
laparoscopic surgery plus postsurgery adjuvant chemotherapy of FOLFOX4
laparoscopic surgery
surgery would be performed by laparoscope
B
open surgery plus postsurgery adjuvant chemotherapy of FOLFOX4
open surgery
surgery would be performed by traditional surgery.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
laparoscopic surgery
surgery would be performed by laparoscope
open surgery
surgery would be performed by traditional surgery.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Beijing Friendship Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
beijing friendship hospital
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
zhongtao zhang, doctor
Role: PRINCIPAL_INVESTIGATOR
beijing friendship hospital, department of general surgery
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beijing Friendship Hospital, Department of General Surgery
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
zhongtao zhang, doctor
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BJLS01
Identifier Type: -
Identifier Source: org_study_id