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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02272894
Recruitment Status : Unknown
Verified July 2014 by Tianjin Medical University Cancer Institute and Hospital.
Recruitment status was:  Recruiting
First Posted : October 23, 2014
Last Update Posted : December 9, 2015
Sponsor:
Collaborators:
The First Affiliated Hospital with Nanjing Medical University
Shanxi Province Cancer Hospital
Beijing Cancer Hospital
Qingdao University
Fudan University
Sun Yat-sen University
Harbin Medical University
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
The First Affiliated Hospital of Dalian Medical University
Qinghai University
Second Hospital of Jilin University
The First Affiliated Hospital of Zhengzhou University
Wulumuqi General Hospital of Lanzhou Military Command
Shandong Provincial Hospital
Nanjing PLA General Hospital
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Gastric Cancer 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 510 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Randomized Controlled Trial to Evaluate Mesenteric Vein (14V) Lymphadenectomy for Gastric Cancer
Study Start Date : July 2014
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

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



Primary Outcome Measures :
  1. overall survival [ Time Frame: 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 :
  1. disease free survival [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Distal Advanced Gastric Cancer
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272894


Contacts
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Contact: Han Liang, Master 086-022-23340123 ext 1061 tjlianghan@126.com

Locations
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China, Tianjin
Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital Recruiting
Tianjin, Tianjin, China, 300060
Contact: Liang Han, Master    086-022-23340123 ext 1061    tjlianghan@126.com   
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
The First Affiliated Hospital with Nanjing Medical University
Shanxi Province Cancer Hospital
Beijing Cancer Hospital
Qingdao University
Fudan University
Sun Yat-sen University
Harbin Medical University
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
The First Affiliated Hospital of Dalian Medical University
Qinghai University
Second Hospital of Jilin University
The First Affiliated Hospital of Zhengzhou University
Wulumuqi General Hospital of Lanzhou Military Command
Shandong Provincial Hospital
Nanjing PLA General Hospital
Investigators
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Principal Investigator: Han Liang, Master Tianjin Medical University Cancer Hospital

Additional Information:

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Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT02272894    
Other Study ID Numbers: E201419A
First Posted: October 23, 2014    Key Record Dates
Last Update Posted: December 9, 2015
Last Verified: July 2014
Keywords provided by Tianjin Medical University Cancer Institute and Hospital:
Gastric Cancer
D2 Lymphadenectomy
Superior Mesenteric Vein Lymph Node
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases