Gastric Cancer
Conditions
Keywords
Gastric Cancer, Prognosis, Omentectomy
Brief summary
This is a phase III, multicenter, prospective, randomized, controlled clinical trial to evaluate the impact of omentectomy for advanced gastric cancer on patient survival.
Detailed description
In order to evaluate the impact of omentectomy for advanced gastric cancer on patient survival, we designed this trial. Patients who received curative gastrectomy were divided into two groups based on whether they underwent omentectomy. The purpose of this study is to prove the non-inferiority of omentum preservation compared with omentectomy in patients with T3-T4a gastric cancer.
Interventions
PROCEDUREType of omentectomy
Experimental group D2 radical gastrectomy with partial omentectomy. Partial omentectomy with preservation of the greater omentum at \>3 cm from the gastroepiploic arcade.Control group with total omentectomy.
Sponsors
Peking University Cancer Hospital & Institute
Shanghai Zhongshan Hospital
Fujian Cancer Hospital
Fujian Medical University Union Hospital
First Affiliated Hospital of Guangxi Medical University
Harbin Medical University
Hebei Medical University Fourth Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
The First Affiliated Hospital with Nanjing Medical University
Changzhi People's Hospital
The First Affiliated Hospital of Air Force Medicial University
First Affiliated Hospital of Kunming Medical University
LanZhou University
Liaoning Cancer Hospital & Institute
The First Affiliated Hospital of Nanchang University
Shandong Provincial Hospital
West China Hospital
Xinjiang Medical University Cancer Hospital
Zhejiang Cancer Hospital
Chinese PLA General Hospital
Sun Yat-sen University Cancer Hosptial
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Had been treated with Radical resection (D2, R0) of gastric cancer (Lymph node≥16); 2. Physical condition and organ function allows to tolerable abdominal surgery; 3. Willing and able to comply with the program during the study period; 4. Written informed consent provided; 5. ≥ 18 and ≤ 70 years of age; preoperative gastric cancer patients with pathologically confirmed; 6. With more than a 6-month life expectancy; 7. No other serious concomitant diseases; Sufficient organ functions; 8. No previous history of chemotherapy or radiotherapy; 9. All patients accept 8 cycles XELOX chemotherapy regimen; 10. Clinical stage: T3-4aN0-+M0; 11 . Macroscopic types :Borrmann I-III; 12\. Not greater curvature tumor; with distal or total gastrectomy； 13. No previous surgery for any abdominal disease, except an appendectomy for appendicitis, a laparoscopic cholecystectomy for gallbladder stones; No previous history of peritonitis, pancreatitis; 14. Karnofsky performance status (KPS)\>60; Eastern Cooperative Oncology Group Performance Status (ECOG): 0-1.
Exclusion criteria
Pregnancy or breast feeding; 2. Patients with Serious liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease or uncontrolled diabetes, hypertension and other chronic systemic diseases, heart disease with Clinical symptoms, such as congestive heart failure, coronary heart disease symptoms, drug is difficult to control arrhythmia, hypertension, or six months had a myocardial infarction attack, or cardiac insufficiency; 3. Organ transplantation patients need immunosuppressive therapy; 4. Severe recurrent infections were not controlled or with other serious concomitant diseases; 5. Patients got other primary malignant tumors (except curable skin basal cell carcinoma and cervical cancer in situ) except gastric cancer within 5 years; 6. Psychiatric disease which require treatment; 7. Have the history of organ transplantation; 8. Within 6 months before study starts and in the process of this study, patients participate in other clinical researches. 9. Advanced gastric cancer with omentum invasion 10. Patients can't treated with XELOX after surgery; 11 . Macroscopic types : Borrmann IV; 12. Tumor invasion of adjacent organ (T4b) or with distant metastasis#M1 #; 13. Tumor invasion the greater curvature invasion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Free Survival(DFS) | 3 years | Disease Free Survivalof the Participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival(OS) | 5 years | Overall Survival of the Participants |
Other
| Measure | Time frame | Description |
|---|---|---|
| The volume of intraoperative blood loss | 1 week | The volume of intraoperative blood loss (IBL) was defined as the total from suction and the weight of gauze sponges at the conclusion of the operation. The Blood loss volume is recorded in milliliters. |
| Postoperative morbidity | 1 month | Postoperative morbidity was defined as the incidence rate of the postoperative complication. The postoperative morbidity were examined within 30 days after surgery. Postoperative morbidity was graded with use of the modified Clavien-Dindo classification of surgical complications. |
Countries
China
Contacts
Primary ContactHan Liang, Master
Backup ContactBik Ke, Doctor
Outcome results
None listed