clinical stage I gastric cancer
Conditions
Interventions
Sponsors
Japan Clinical Oncology Group(JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven gastric adenocarcinoma. 2) cStage IA or IB. 3) No indication of endoscopic mucosal resection (EMR) in a cN0 case. 4) Tumor located in the middle or lower 1/3 of the stomach and indication for distal gastrectomy. 5) No invasion to duodenum. 6) Aged 20 to 80 year. 7) PS (ECOG) of 0 or 1. 8) Body mass index <30. 9) Not recurrence after EMR. 10) No history of upper abdominal surgery and no history of intestinal resection. 11) No prior treatment of chemotherapy or radiation therapy against any other malignancies. 12) Sufficient organ functions. 13) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ. 2) Women during pregnancy or breast-feeding. 3) Severe mental disease. 4) Continuous systemic steroid therapy. 5) History of myocardial infarction or unstable angina pectoris within six months. 6) Uncontrollable hypertension. 7) Uncontrollable diabetes millutus or administration of insulin. 8) Severe respiratory disease requiring continuous oxygen therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of anastomotic leakage or pancreatic fistula | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, recurrence-free survival, proportion of LADG completion, proportion of conversion to open surgery, adverse events, short-term clinical outcomes | — |
Countries
Japan
Contacts
Public ContactHitoshi Katai
JCOG0703 Coordinating Office Division of Gastric Surgery, National Cancer Center Hospital
Outcome results
None listed