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Trial Title:
A Trial to Evaluate the Superior Mesenteric Vein (14V) Lymphadenectomy for Distal Advanced Gastric Cancer
NCT ID:
NCT02272894
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
Gastric Cancer
D2 Lymphadenectomy
Superior Mesenteric Vein Lymph Node
Study type:
Observational [Patient Registry]
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Dissection of the Superior Mesenteric Vein Lymph Node
Description:
14v lymph node dissection
Arm group label:
Group A
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.
Criteria for eligibility:
Study pop:
Distal Advanced Gastric Cancer
Sampling method:
Probability Sample
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;
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Recruiting
Contact:
Last name:
Liang Han, Master
Phone:
086-022-23340123
Phone ext:
1061
Email:
tjlianghan@126.com
Start date:
July 2014
Completion date:
December 2016
Lead sponsor:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Collaborator:
Agency:
Shanxi Province Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Collaborator:
Agency:
Qingdao University
Agency class:
Other
Collaborator:
Agency:
Fudan University
Agency class:
Other
Collaborator:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
Harbin Medical University
Agency class:
Other
Collaborator:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Dalian Medical University
Agency class:
Other
Collaborator:
Agency:
Qinghai University
Agency class:
Other
Collaborator:
Agency:
Second Hospital of Jilin University
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Zhengzhou University
Agency class:
Other
Collaborator:
Agency:
Wulumuqi General Hospital of Lanzhou Military Command
Agency class:
Other
Collaborator:
Agency:
Shandong Provincial Hospital
Agency class:
Other
Collaborator:
Agency:
Nanjing PLA General Hospital
Agency class:
Other
Source:
Tianjin Medical University Cancer Institute and Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02272894