Back to resultsA Multicenter Clinical Trial on Laparoscopic Gastric Cancer Surgery Compared With Open Surgery
Primary Purpose
Locally Advanced Gastric Cancer
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
open surgery
laparoscopic surgery
Sponsored by
About this trial
This is an interventional treatment trial for Locally Advanced Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- 18 years ~ 75 years;
- the primary adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, poorly differentiated adenocarcinoma);
- clinical stage T2-4a, N0-3, M0 (according to AJCC-7th TNM staging);
- to perform distal gastrectomy, D2 lymph node dissection surgical can obtain R0 resection (multiple primary cancers also apply)
- ECOG performance status 0/1;
- ASA score I-III;
- patient informed consent.
Exclusion Criteria:
- pregnant or lactating women;
- serious mental illness;
- upper abdominal surgery (except laparoscopic cholecystectomy );
- gastric surgery (including for gastric ESD / EMR);
- imaging examinations showed regional integration lymph nodes (maximum diameter ≥ 3cm)
- other malignant diseases in 5 years;
- implemented or recommended neoadjuvant therapy in patients with gastric cancer ;
- have unstable angina or myocardial infarction within six months; (9) have cerebral infarction or cerebral hemorrhage within 6 months; (10) sustained systemic glucocorticoid treatment history within 1 month; (11) have other diseases needed operative treatment at the same time; (12) complications (bleeding, perforation, obstruction) required emergency surgery; (13) Pulmonary function tests FEV1 <50% of predicted value.
Sites / Locations
- Union Hospital, Huazhong University of Science and TechnologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
open surgery
laparoscopic surgery
Arm Description
Conventional procedure
Minimum invasive procedure
Outcomes
Primary Outcome Measures
3-year disease free survival rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02302794
Brief Title
A Multicenter Clinical Trial on Laparoscopic Gastric Cancer Surgery Compared With Open Surgery
Official Title
Prospective Randomized Controlled Multicenter Clinical Trial for Comparison of Long-term Outcomes Between Laparoscopy-assisted and Open Distal Subtotal Gastrectomy With D2 Lymphadenectomy for Locally Advanced Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Cai Kailin
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
evaluate the long-term efficacy and safety of oncology between D2 laparoscopic approach distal gastric resection (distal gastrectomy, D2 lymph node dissection) with the current standard surgical treatment model D2 open approach distal gastric resection (distal gastrectomy, D2 lymphadenectomy).
Detailed Description
Study type：Interventional Study phase：Phase III Objectives of Study：to evaluate the long-term efficacy and safety of oncology between D2 laparoscopic approach distal gastric resection (distal gastrectomy, D2 lymph node dissection) with the current standard surgical treatment model D2 open approach distal gastric resection (distal gastrectomy, D2 lymphadenectomy).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1056 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
open surgery
Arm Type
Active Comparator
Arm Description
Conventional procedure
Arm Title
laparoscopic surgery
Arm Type
Experimental
Arm Description
Minimum invasive procedure
Intervention Type
Procedure
Intervention Name(s)
open surgery
Other Intervention Name(s)
group A, open
Intervention Description
Patients in this arm undergo radical resection of gastric cancer in open surgery.Open surgery is a conventional technique for gastric cancer patients.
Intervention Type
Procedure
Intervention Name(s)
laparoscopic surgery
Other Intervention Name(s)
group B, laparoscopic
Intervention Description
Patients in this arm undergo radical resection of gastric cancer in laparoscopic surgery.Laparoscopic surgery is a new and minimum invasive technique for gastric cancer patients.
Primary Outcome Measure Information:
Title
3-year disease free survival rate
Time Frame
three years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years ~ 75 years;
the primary adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, poorly differentiated adenocarcinoma);
clinical stage T2-4a, N0-3, M0 (according to AJCC-7th TNM staging);
to perform distal gastrectomy, D2 lymph node dissection surgical can obtain R0 resection (multiple primary cancers also apply)
ECOG performance status 0/1;
ASA score I-III;
patient informed consent.
Exclusion Criteria:
pregnant or lactating women;
serious mental illness;
upper abdominal surgery (except laparoscopic cholecystectomy );
gastric surgery (including for gastric ESD / EMR);
imaging examinations showed regional integration lymph nodes (maximum diameter ≥ 3cm)
other malignant diseases in 5 years;
implemented or recommended neoadjuvant therapy in patients with gastric cancer ;
have unstable angina or myocardial infarction within six months; (9) have cerebral infarction or cerebral hemorrhage within 6 months; (10) sustained systemic glucocorticoid treatment history within 1 month; (11) have other diseases needed operative treatment at the same time; (12) complications (bleeding, perforation, obstruction) required emergency surgery; (13) Pulmonary function tests FEV1 <50% of predicted value.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guobin Wang, MD,PhD
Phone
+86 027 85726139
Email
wangguobin1954@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guobin Wang, MD,PhD
Organizational Affiliation
Wuhan Union Hospital, China
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kaixiong Tao, MD,PhD
Organizational Affiliation
Wuhan Union Hospital, China
Official's Role
Study Director
Facility Information:
Facility Name
Union Hospital, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guobin Wang, MD,PhD
Phone
+86 027 85726139
Email
wangguobin1954@126.com
First Name & Middle Initial & Last Name & Degree
Xinghua Liu, MD
First Name & Middle Initial & Last Name & Degree
Shi Wang, MD
12. IPD Sharing Statement
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A Multicenter Clinical Trial on Laparoscopic Gastric Cancer Surgery Compared With Open Surgery
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