clinical stage T1-4aN0-3 Gastric Cancer
Conditions
Interventions
A:Laparoscopic gastrectomy with nodal dissection
B:Robot-assisted gastrectomy with nodal dissection
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven gastric adenocarcinoma by endoscopic biopsy. 2) Clinical T1-T4a and N0-N3 diagnosed by contrast-enhanced abdominal computed tomography and endoscopic assessment. Metastatic lymph nodes are defined as swollen lymph nodes that are larger than 10 mm in diameter in major axis or 8 mm in diameter in minor axis by CT scan. 3) H0P0M0 and no bulky metastatic lymph nodes (bulky N2) by contrast-enhanced chest - abdominal computed tomography. 4) Clinical T2 located in the U area not invading the greater curvature (Gre). 5) In case without preceding EMR or ESD, the diagnosis is clinical N1-3 or cN0 without indication for EMR(ESD). 6) In case with preceding EMR or ESD, the following conditions are fulfilled: i) pathological findings require additional gastrectomy, ii) within 91 days from EMR or ESD, iii) perforation by EMR or ESD is not considered. 7) Expected R0 surgery 8) Neither Borrmann type 4 nor large (>8cm) type 3 9) No invasion to esophagus and duodenum. 10) Not a stump cancer of stomach 11) Aged 20 years old or older 12) Eastern Cooperative Oncology Group performance status of 0 or 1. 13) Body mass index (BMI) is less than 30. 14) No history of upper abdominal surgery except laparoscopic cholecystectomy. 15) No prior abdominal radiotherapy for any malignancies. History of chemotherapy and/or endocrine therapy is eligible. 16) Adequate organ functions defined as; i) WBC of 3,000/mm3 or more ii) Platelet count 100,000/mm3 or more iii) T.Bil of 2.0 mg/dL or less iv) AST of 100 IU/L or less v) ALT of 100 IU/L or less vi) Creatinine of 1.5 mg/dL or less 17) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancies. 2) Infectious disease requiring systemic treatment. 3) Body temperature of 38 degrees Celsius or higher. 4) During pregnancy, within 28 days postpartum, or during lactation. 5) Severe mental disease. 6) Receiving continuous systemic corticosteroid or immunosuppressant treatment. 7) History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration. 8) Poorly controlled valve disease, dilated or hypertrophic cardiomyopathy 9) HIV antibody positive 10) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema based on chest computed tomography
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of postoperative intra-abdominal infectious complications including leakage, pancreatic fistula, and abdominal abscess with Clavien-Dindo grade II and more | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of postoperative complications with Clavien-Dindo grade II and more, incidence of postoperative complications with Clavien-Dindo grade IIIA and more, incidence of postoperative intra-abdominal infectious complications with Clavien-Dindo grade IIIA and more, relapse-free survival, overall survival, proportion of robot-assisted gastrectomy completion, proportion of laparoscopic gastrectomy completion, proportion of conversion to open surgery, proportion of surgery-related death, short-term clinical outcomes after gastrectomy | — |
Countries
Japan
Contacts
Public ContactRie Makuuchi
JCOG1907 Coordinating Office Cancer Institute Hospital of JFCR Department of Gastric Surgery
Outcome results
None listed