NCT02248038

Brief Summary

The purpose of this study is to verify the 5-year disease free survival (DFS) of resectable colorectal cancer after laparoscopic surgery according to a Chinese Operative Standard was not inferior to open surgery.

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
1,300

participants targeted

Target at P75+ for phase_3 colorectal-cancer

Timeline
Completed

Started Jun 2014

Typical duration for phase_3 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

June 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

5 years

First QC Date

September 9, 2014

Last Update Submit

September 23, 2014

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

  • 5 years diseases free survival rate

    five years

  • 5 years overall survival rate

    five years

Study Arms (2)

open surgery

ACTIVE COMPARATOR

Conventional procedure

Procedure: open surgery

laparoscopic surgery

EXPERIMENTAL

Minimum invasive procedure

Procedure: laparoscopic surgery

Interventions

open surgeryPROCEDURE

Patients in this arm undergo radical resection of colon cancer in open surgery.Open surgery is a conventional technique for colorectal cancer patients.

Also known as: open
open surgery
laparoscopic surgeryPROCEDURE

Patients in this arm undergo radical resection of colon cancer in laparoscopic surgery.Laparoscopic surgery is a new and minimum invasive technique for colorectal cancer patients.

Also known as: laparoscopic
laparoscopic surgery

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • informed consent
  • single colorectal adenocarcinoma, located at any segment of the colorectum with lower margin 5cm or more to the dental line
  • cTNM：colon cancer T1-4N1-2M0，rectal cancer T1-3N1-2M0，longest diameter no more than 6cm
  • age less than 80 years old
  • normal blood routine test and hepatic or renal function test
  • no gastrointestinal surgery history or chemotherapy, radiation, No complete obstruction.

You may not qualify if:

  • severe comorbidity such as heart attack or stroke, malignance in 5 years
  • can not tolerate to general anesthesia, pneumoperitoneum or surgery
  • pregnant or during breast-feeding period
  • attending other clinical trial involving therapy
  • cannot or disagree to attending the clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Union Hospital, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Conversion to Open SurgeryLaparoscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

EndoscopyMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Guobin Wang, MD,PhD

    Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    STUDY CHAIR

  • Kaixiong Tao, MD,PhD

    Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    STUDY DIRECTOR

  • Kailin Cai, MD,PhD

    Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    STUDY DIRECTOR

  • Shi Wang, MD

    Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate chief physician of gastrointestinal surgery

Study Record Dates

First Submitted

September 9, 2014

First Posted

September 25, 2014

Study Start

June 1, 2014

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

September 25, 2014

Record last verified: 2014-09

Locations

CN(1)