A Trial to Evaluate the Superior Mesenteric Vein (14V) Lymphadenectomy for Distal Advanced Gastric Cancer
December 8, 2015 updated by: Tianjin Medical University Cancer Institute and Hospital
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group A
D2 Radical Gastrectomy Adding 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
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.
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Han Liang, Master, Tianjin Medical University Cancer Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- E201419A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.