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

Randomized Controlled Trial to Evaluate Mesenteric Vein (14V) Lymphadenectomy for Gastric Cancer

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.

Study Overview

• Status: Unknown
• Conditions: Gastric Cancer
• Intervention / Treatment: Procedure: Dissection of the Superior Mesenteric Vein Lymph Node

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 Type: Observational
• Enrollment (Anticipated): 510

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Recruiting
      • Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital
      • Contact: Liang Han, Master; Phone Number: 1061 086-022-23340123; Email: tjlianghan@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Distal Advanced Gastric Cancer

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A; D2 Radical Gastrectomy Adding Dissection of the Superior Mesenteric Vein Lymph Node	Procedure: Dissection of the Superior Mesenteric Vein Lymph Node; 14v lymph node dissection
Group B; D2 Radical Gastrectomy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
disease free survival	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.	3 years

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; Shanxi Province Cancer Hospital; Sun Yat-sen University; Fudan University; Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Peking University Cancer Hospital & Institute; Qinghai University; Qingdao University; Shandong Provincial Hospital; The First Affiliated Hospital of Zhengzhou University; Harbin Medical University; Second Hospital of Jilin University; The First Affiliated Hospital of Dalian Medical University; Nanjing PLA General Hospital; Wulumuqi General Hospital of Lanzhou Military Command
• Investigators: Principal Investigator: Han Liang, Master, Tianjin Medical University Cancer Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): November 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: September 15, 2014
• First Submitted That Met QC Criteria: October 21, 2014
• First Posted (Estimate): October 23, 2014

Study Record Updates

• Last Update Posted (Estimate): December 9, 2015
• Last Update Submitted That Met QC Criteria: December 8, 2015
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Gastric Cancer; D2 Lymphadenectomy; Superior Mesenteric Vein Lymph Node
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: E201419A