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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02272894
• Other study ID #: E201419A
• Status: Recruiting
• Phase: N/A
• First received: September 15, 2014
• Last updated: December 8, 2015
• Start date: July 2014
• Est. completion date: December 2016

Study information

• Verified date: July 2014
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Han Liang, Master
• Phone: 086-022-23340123
• Email: tjlianghan[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 510
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Dissection of the Superior Mesenteric Vein Lymph Node
14v lymph node dissection

Locations

Country	Name	City	State
China	Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital	Tianjin	Tianjin

Sponsors (16)

Lead Sponsor

Collaborator

Tianjin Medical University Cancer Institute and Hospital

Beijing Cancer Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Fudan University, Harbin Medical University, Nanjing PLA General Hospital, Qingdao University, Qinghai University, Second Hospital of Jilin University, Shandong Provincial Hospital, Shanxi Province Cancer Hospital, Sun Yat-sen University, The First Affiliated Hospital of Dalian Medical University, The First Affiliated Hospital of Zhengzhou University, The First Affiliated Hospital with Nanjing Medical University, Wulumuqi General Hospital of Lanzhou Military Command

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No