A Multicenter Clinical Trial on Laparoscopic Colorectal Cancer Surgery Compared With Open Surgery

Colorectal Cancer Clinical Trial

Official title:

A Multicenter Randomized Clinical Trial on Laparoscopic Colorectal Cancer Surgery Compared With Open Surgery in China

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

• Colorectal Cancer
• Colorectal Neoplasms

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