A Trial to Evaluate the Superior Mesenteric Vein (14V) Lymphadenectomy for Distal Advanced Gastric Cancer

• Conditions: Gastric Cancer
• Interventions: Procedure: Dissection of the Superior Mesenteric Vein Lymph Node

• Registration Number: NCT02272894
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

This trial is going to evaluate the advantage of D2 radical gastrectomy plus 14v lymph node dissection in 3-year survival rates of advanced gastric cancers.

Detailed Description

Radical surgery is still the only possible way to cure gastric cancer. In Japan, South Korea and other countries, due to the popularity of screening and Improved surgical procedures, there has been great improvement in overall survival. Standard D2 Gastrectomy has been the standard operation for advanced gastric cancer. However, there is no unanimous consensus whether Standard D2 Gastrectomy plus 14v lymph node dissection is needed.Till now, it is difficult to stage the 14V lymph node as regional lymph nodes metastasis or distant metastasis. And it is urgent to explore the necessity of 14v lymph node dissection in advanced gastric cancer.So a prospective randomized controlled study will to carry out to evaluate the effects of D2 radical gastrectomy plus 14v lymph node dissection compared with D2 radical gastrectomy.

Study Timeline

• Status Verified: 2014-07
• Study Start: 2014-07
• Study First Submitted: 2014-09-15
• Study First Submitted QC: 2014-10-21
• Study First Posted: 2014-10-23
• Last Update Submitted: 2015-12-08
• Last Update Posted: 2015-12-09
• Primary Completion: 2016-11
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 510

Inclusion Criteria

• Curative D2 or D2+ operation had been performed;
• Physical condition and organ function allows to tolerable abdominal surgery;
• Willing and able to comply with the program during the study period;
• Aged 18 to 70 years, preoperative gastric cancer patients with pathologically confirmed;
• With more than a 6-month life expectancy;
• No other serious concomitant diseases;
• No adjuvant chemotherapy before recurrence;
• Karnofsky performance status scale ≥ 60;
• All patients accept 6 cycles XELOX chemotherapy regimen

Exclusion Criteria

• Pregnancy or breast feeding;
• Women of childbearing age do not take contraceptive measures;
• Organ transplantation patients need immunosuppressive therapy;
• Five years after the trial begin,other malignant tumor occur;
• While using other experimental drug or other clinical trials are being;
• Can not take oral medications;
• Mentally disordered;
• Severe recurrent infections were not controlled or with other serious concomitant diseases;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	Dissection of the Superior Mesenteric Vein Lymph Node	D2 Radical Gastrectomy Adding Dissection of the Superior Mesenteric Vein Lymph Node

Primary Outcome Measures

Name	Time	Method
overall survival	3 years	Overall survival (OS) was defined as the length of time from the date of randomization to the date of death of various reasons.

Secondary Outcome Measures

Name	Time	Method
disease free survival	3 years	Disease free survival (DFS) was defined as the length of time from the date of randomization to the date of first documentation of relapse of gastric cancer or any other type of cancer or death.

Trial Locations

Locations (1)

Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital; 🇨🇳 Tianjin, Tianjin, China