Clinical trial NCT02272894: A Trial to Evaluate the Superior Mesenteric Vein (14V) Lymphadenectomy for Distal Advanced Gastric Cancer
Official title: Randomized Controlled Trial to Evaluate Mesenteric Vein (14V) Lymphadenectomy for Gastric Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer
Keywords: Gastric Cancer
D2 Lymphadenectomy
Superior Mesenteric Vein Lymph Node
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital with Nanjing Medical University
name: Shanxi Province Cancer Hospital
name: Peking University Cancer Hospital & Institute
name: Qingdao University
name: Fudan University
name: Sun Yat-sen University
name: Harbin Medical University
name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: The First Affiliated Hospital of Dalian Medical University
name: Qinghai University
name: Second Hospital of Jilin University
name: The First Affiliated Hospital of Zhengzhou University
name: Wulumuqi General Hospital of Lanzhou Military Command
name: Shandong Provincial Hospital
name: Nanjing PLA General Hospital
First posted: 2014-10-23
Enrollment: 510
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Distal Advanced Gastric Cancer

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.

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.

Eligibility 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;

Primary outcomes:
measure: overall survival
timeFrame: 3 years
Secondary outcomes:
measure: disease free survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Hospital
name: Han Liang, Master
role: PRINCIPAL_INVESTIGATOR
References: