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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02248038
Other study ID # ChiCTR-TRC-14004767
Secondary ID ChiCTR-TRC-14004
Status Active, not recruiting
Phase Phase 3
First received September 9, 2014
Last updated September 23, 2014
Start date June 2014
Est. completion date June 2019

Study information

Verified date September 2014
Source Huazhong University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority China: National Health and Family Planning Commission
Study type Interventional

Clinical Trial 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.


Description:

Study type:Interventional Study phase:Phase III Objectives of Study:to verify the 5-year DFS of resectable colorectal cancer after laparoscopic surgery according to a Chinese Operative Standard was not inferior to open surgery.

Study design:Randomized parallel control


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1300
Est. completion date June 2019
Est. primary completion date June 2019
Accepts healthy volunteers No
Gender Both
Age group N/A to 80 Years
Eligibility Inclusion Criteria:

1. informed consent

2. single colorectal adenocarcinoma, located at any segment of the colorectum with lower margin 5cm or more to the dental line

3. cTNM:colon cancer T1-4N1-2M0,rectal cancer T1-3N1-2M0,longest diameter no more than 6cm

4. age less than 80 years old

5. normal blood routine test and hepatic or renal function test

6. no gastrointestinal surgery history or chemotherapy, radiation, No complete obstruction.

Exclusion Criteria:

1. severe comorbidity such as heart attack or stroke, malignance in 5 years

2. can not tolerate to general anesthesia, pneumoperitoneum or surgery

3. pregnant or during breast-feeding period

4. attending other clinical trial involving therapy

5. cannot or disagree to attending the clinical trial

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Union Hospital, Huazhong University of Science and Technology Wuhan Hubei

Sponsors (5)

Lead Sponsor Collaborator
Cai Kailin Huazhong University of Science and Technology, Nanfang Hospital of Southern Medical University, Peking Union Medical College Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 5 years diseases free survival rate five years Yes
Primary 5 years overall survival rate five years Yes
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