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

Locally Advanced Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02302794
• Other study ID #: ChiCTR-TRC-14004877
• Status: Recruiting
• Phase: Phase 3
• First received: November 25, 2014
• Last updated: November 25, 2014
• Start date: August 2014
• Est. completion date: August 2016

Study information

• Verified date: July 2014
• Source: Huazhong University of Science and Technology
• Contact: Guobin Wang, MD,PhD
• Phone: +86 027 85726139
• Email: wangguobin1954[@]126.com
• Is FDA regulated: No
• Health authority: China:Health and Family Planning Commision
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1056
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. 18 years ~ 75 years;

2. the primary adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, poorly differentiated adenocarcinoma);

3. clinical stage T2-4a, N0-3, M0 (according to AJCC-7th TNM staging);

4. to perform distal gastrectomy, D2 lymph node dissection surgical can obtain R0 resection (multiple primary cancers also apply)

5. ECOG performance status 0/1;

6. ASA score I-III;

7. patient informed consent.

Exclusion Criteria:

1. pregnant or lactating women;

2. serious mental illness;

3. upper abdominal surgery (except laparoscopic cholecystectomy );

4. gastric surgery (including for gastric ESD / EMR);

5. imaging examinations showed regional integration lymph nodes (maximum diameter = 3cm)

6. other malignant diseases in 5 years;

7. implemented or recommended neoadjuvant therapy in patients with gastric cancer ;

8. 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.

Study Design

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

Related Conditions & MeSH terms

• Locally Advanced Gastric Cancer
• Stomach Neoplasms

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Cai Kailin

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year disease free survival rate		three years	Yes