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

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

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: open surgery; Procedure: laparoscopic surgery

Detailed 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

• Study Type: Interventional
• Enrollment (Anticipated): 1300
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Union Hospital, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 80 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: open surgery; Conventional procedure	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.; Other Names: open
EXPERIMENTAL: laparoscopic surgery; Minimum invasive procedure	Procedure: 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.; Other Names: laparoscopic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
5 years diseases free survival rate	five years
5 years overall survival rate	five years

Collaborators and Investigators

• Sponsor: Cai Kailin
• Collaborators: Peking Union Medical College Hospital; Second Affiliated Hospital, School of Medicine, Zhejiang University; Huazhong University of Science and Technology; Nanfang Hospital of Southern Medical University
• Investigators: Study Director: Kailin Cai, MD,PhD, Wuhan Union Hospital, China; Principal Investigator: Shi Wang, MD, Wuhan Union Hospital, China

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (ANTICIPATED): June 1, 2019
• Study Completion (ANTICIPATED): June 1, 2019

Study Registration Dates

• First Submitted: September 9, 2014
• First Submitted That Met QC Criteria: September 23, 2014
• First Posted (ESTIMATE): September 25, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): September 25, 2014
• Last Update Submitted That Met QC Criteria: September 23, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: ChiCTR-TRC-14004767 (REGISTRY: ChiCTR-TRC-14004767)