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A Randomized Controlled Study of the Superior Mesenteric Vein Lymph Node (14V) Metastasis With Advanced Gastric Cancer
Conditions
Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
Gastric Cancer, D2 Lymphadenectomy, Superior Mesenteric Vein Lymph Node
Study Type
Observational [Patient Registry]
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Intervention
Name: Dissection of the Superior Mesenteric Vein Lymph Node
Type: Procedure
Overall Status
Recruiting
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
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
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;
- 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;
Location
Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital
Tianjin, Tianjin, China
Status: Recruiting
Contact: Liang Han, Master - 086-022-23340123 - tjlianghan@126.com
Start Date
July 2014
Completion Date
November 2015
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Source
Tianjin Medical University Cancer Institute and Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page