Gastric cancer
Conditions
Interventions
laparoscopic / robot-assisted proximal gastrectomy with D2 dissection
Sponsors
Clinical Study Group of Osaka University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven gastric adenocarcinoma without neoadjuvant chemotherapy. 2) A tumor mainly located in upper-third of stomach with diameter of 5cm or less. Absence of tumor invasion to esophagus or greater curvature line. 3) Clinical stage T2-3, N0-1. In case of N1, metastatic nodes can be resected by proximal gastrectomy (D2 dissection). 4) Aged 20 years or older. 5) PS (ECOG) of 0,1, and 2. 6) Body mass index less than 30. 7) Sufficient organ functions. WBC >= 3,000/mm3, <12,000/mm3 Platelet >= 100,000/mm3 Hemoglobin >= 8 g/dL AST =< 100 IU/L ALT =< 100 IU/L T.Bil =< 2.0 mg/dL Creatinine =< 1.5 mg/dL 8) No history of gastrectomy, pancreatectomy, or splenectomy. 9) No prior treatment of radiation therapy on upper abdomen. History of chemotherapy, hormone therapy, or molecular targeted therapy is eligible. 10) 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) Pregnancy, possible pregnancy, or breast-feeding. 4) Severe psychiatric disease. 5) Continuous systemic steroid or immune-suppressive drug therapy. 6) Unstable angina pectoris, or history of myocardial infarction within six months. 7) Poorly controlled hypertension. 8) Poorly controlled diabetes mellitus in spite of continuous use of insulin. 9) Severe respiratory disease requiring continuous oxygen therapy. 10) Severe renal dysfunction requiring dialysis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year relapse-free survival | — |
Countries
Japan
Contacts
Public ContactTakuya Hamakawa
National Hospital Organization Osaka National Hospital Department of Surgery
Outcome results
None listed