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

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ClinicalTrials.gov Identifier: NCT00788281
Recruitment Status : Unknown
Verified November 2008 by Beijing Friendship Hospital.
Recruitment status was:  Recruiting
First Posted : November 10, 2008
Last Update Posted : November 13, 2008
Sponsor:
Information provided by:
Beijing Friendship Hospital

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Procedure: laparoscopic surgery Procedure: open surgery Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2008
Estimated Primary Completion Date : April 2011
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. disease free survival rate [ Time Frame: 3 year ]
  2. tumor residual rate of LRM and CRM [ Time Frame: 1 week ]
  3. operation mortality [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. survival rate [ Time Frame: 3 year ]
  2. survival rate [ Time Frame: 5 year ]
  3. local recurrence rate [ Time Frame: 5 year ]
  4. operation time [ Time Frame: at the end of operation ]
  5. blood lost [ Time Frame: during operation ]
  6. analgesic dosage [ Time Frame: 1,2 and 3 days post surgery ]
  7. evacuating time [ Time Frame: post surgery ]
  8. operation morbidity [ Time Frame: 2 months ]
  9. transfer to open surgery [ Time Frame: during operation ]
  10. fee [ Time Frame: peri-operation ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: the department of general surgery, beijing friendship hospital
ClinicalTrials.gov Identifier: NCT00788281     History of Changes
Other Study ID Numbers: BJLS01
First Posted: November 10, 2008    Key Record Dates
Last Update Posted: November 13, 2008
Last Verified: November 2008

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