Adjuvant Capecitabine Versus Observation Alone in Curatively Resected Stage IB Gastric Cancer((KCSG ST14-05): CATALYSIS
Trial Parameters
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Brief Summary
multi-center, prospective, randomized, open-label phase III
Eligibility Criteria
Inclusion Criteria: * Curatively resected gastric or gastroesophageal junction adenocarcinoma * Pathologic stage IB (by AJCC 6th edition) with at least one additional risk factor for recurrence (additional risk factors for recurrence include age \>65 years, male gender, presence of lymphovascular invasion, presence of perineural invasion). * Age: 18 -74years * ECOG performance status: 0-2 * Adequate bone marrow function (ANC \>1,500/uL, Platelets 100,000/uL, and Hb \> 8.0 g/dL) * Adequate renal function (serum creatinine \< 1.5 mg/dL) * Adequate hepatic function (bilirubin \< 1.5 mg/dL, ALT and AST \< 3 times upper limit of normal) * Written informed consent Exclusion Criteria: * Pregnant or lactating women. * Women of childbearing potential with either a positive pregnancy test at baseline. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-child bearing potential. * Sexually active males and females (of childbearing potential) unwilling to