NCT00788281

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2 colorectal-cancer

Timeline
Completed

Started Apr 2008

Longer than P75 for phase_2 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 10, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

November 13, 2008

Status Verified

November 1, 2008

Enrollment Period

3 years

First QC Date

November 7, 2008

Last Update Submit

November 12, 2008

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (3)

  • disease free survival rate

    3 year

  • tumor residual rate of LRM and CRM

    1 week

  • operation mortality

    2 months

Secondary Outcomes (10)

  • survival rate

    3 year

  • survival rate

    5 year

  • local recurrence rate

    5 year

  • operation time

    at the end of operation

  • blood lost

    during operation

  • +5 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL

laparoscopic surgery plus postsurgery adjuvant chemotherapy of FOLFOX4

Procedure: laparoscopic surgery

B

ACTIVE COMPARATOR

open surgery plus postsurgery adjuvant chemotherapy of FOLFOX4

Procedure: open surgery

Interventions

laparoscopic surgeryPROCEDURE

surgery would be performed by laparoscope

A
open surgeryPROCEDURE

surgery would be performed by traditional surgery.

B

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Friendship Hospital, Department of General Surgery

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

LaparoscopyConversion to Open Surgery

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • zhongtao zhang, doctor

    beijing friendship hospital, department of general surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

jin wang, doctor

CONTACT

86-10-63138712zhangzht@medmail.com.cn

xiaotian zhang, doctor

CONTACT

86-10-88196561zhangxtxx@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 7, 2008

First Posted

November 10, 2008

Study Start

April 1, 2008

Primary Completion

April 1, 2011

Study Completion

April 1, 2016

Last Updated

November 13, 2008

Record last verified: 2008-11

Locations

CN(1)