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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2008 by Beijing Friendship Hospital
Sponsor:
Information provided by:
Beijing Friendship Hospital
ClinicalTrials.gov Identifier:
NCT00788281
First received: November 7, 2008
Last updated: November 12, 2008
Last verified: November 2008
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014