gastric cancer
Conditions
Interventions
LATG or LAPG with nodal dissection with D1, D1+ or D2 lymph node dissection
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven gastric adenocarcinoma. 2) Clinical stage T1N0, T1N(+)*, or T2N0 according to the 14th edition of Japanese Classification of Gastric Carcinoma (3rd English edition). *T1N(+) corresponds to T1N1 according to the 13th edition of Japanese Classification of Gastric Carcinoma (2nd English edition). 3) In case of T2N0, tumor does not involve greater curvature 4) In case without preceding endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD), either 'cN(+)' or 'cN0 and no indication of EMR or ESD' is eligible. 5) In case with preceding EMR or ESD, the following conditions are all fulfilled: i) pathological findings require additional gastrectomy ii) within 91 days from EMR or ESD iii) no perforation by EMR or ESD 6) R0 resection is expected by total gastrectomy or proximal gastrectomy. 7) No invasion to duodenum or esophagus. 8) Aged 20 to 80 years. 9) PS (ECOG) of 0 or 1. 10) Body mass index less than 30. 11) No history of upper abdominal surgery and no history of intestinal resection except for appendectomy. 12) No prior treatment of chemotherapy or radiation therapy against any other malignancies. History of hormone therapy after more than 1 year from the last administration is eligible. 13) Sufficient organ functions. i. WBC >= 3,000/mm3 ii. Platelet >= 100,000/mm3 iii. T.Bil =< 2.0 mg/dL iv. AST =< 100 IU/L v. ALT =< 100 IU/L vi. Creatinine =< 1.5 mg/dL 14) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy. 2) Infectious disease with systemic therapy indicated. 3) Body temperature of 38 or more degrees Celsius. 4) Pregnancy, possible pregnancy, within 28 days after delivery or breast-feeding. 5) Severe psychiatric disease. 6) Continuous systemic steroid or immune-suppressive drug therapy. 7) Unstable angina pectoris, or history of myocardial infarction within six months. 8) Poorly controlled hypertension. 9) Poorly controlled diabetes mellitus in spite of continuous use of insulin. 10) Severe respiratory disease requiring continuous oxygen therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of anastomotic leak | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, relapse-free survival, proportion of LATG or LAPG completion, proportion of conversion to open surgery, adverse events, and short-term clinical outcomes | — |
Countries
Japan
Contacts
Public ContactHitoshi Katai
JCOG1401 Coordinating Office Gastric Surgery Division, National Cancer Center Hospital
Outcome results
None listed