A Multi-Center Randomised Controlled Study to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer
This study is currently recruiting participants.
Verified November 2008 by Beijing Friendship Hospital
Sponsor:
Beijing Friendship Hospital
Information provided by:
Beijing Friendship Hospital
ClinicalTrials.gov Identifier:
NCT00788281
First received: November 7, 2008
Last updated: November 12, 2008
Last verified: November 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Procedure: laparoscopic surgery Procedure: open surgery |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Beijing Friendship Hospital:
Primary Outcome Measures:
- disease free survival rate [ Time Frame: 3 year ] [ Designated as safety issue: No ]
- tumor residual rate of LRM and CRM [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- operation mortality [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- survival rate [ Time Frame: 3 year ] [ Designated as safety issue: No ]
- survival rate [ Time Frame: 5 year ] [ Designated as safety issue: No ]
- local recurrence rate [ Time Frame: 5 year ] [ Designated as safety issue: No ]
- operation time [ Time Frame: at the end of operation ] [ Designated as safety issue: No ]
- blood lost [ Time Frame: during operation ] [ Designated as safety issue: Yes ]
- analgesic dosage [ Time Frame: 1,2 and 3 days post surgery ] [ Designated as safety issue: No ]
- evacuating time [ Time Frame: post surgery ] [ Designated as safety issue: No ]
- operation morbidity [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
- transfer to open surgery [ Time Frame: during operation ] [ Designated as safety issue: No ]
- fee [ Time Frame: peri-operation ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | April 2016 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00788281
Contacts
| Contact: jin wang, doctor | 86-10-63138712 | zhangzht@medmail.com.cn |
| Contact: xiaotian zhang, doctor | 86-10-88196561 | zhangxtxx@gmail.com |
Locations
| China, Beijing | |
| Beijing Friendship Hospital, Department of General Surgery | Recruiting |
| Beijing, Beijing, China, 100050 | |
| Contact: zhongtao zhang, doctor | |
| Principal Investigator: zhongtao zhang, doctor | |
Sponsors and Collaborators
Beijing Friendship Hospital
Investigators
| Principal Investigator: | zhongtao zhang, doctor | beijing friendship hospital, department of general surgery |
More Information
No publications provided
| Responsible Party: | the department of general surgery, beijing friendship hospital |
| ClinicalTrials.gov Identifier: | NCT00788281 History of Changes |
| Other Study ID Numbers: | BJLS01 |
| Study First Received: | November 7, 2008 |
| Last Updated: | November 12, 2008 |
| Health Authority: | China: Food and Drug Administration |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 19, 2013