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OncoMatch/Clinical Trials/NCT01917552

Adjuvant Capecitabine Versus Observation Alone in Curatively Resected Stage IB Gastric Cancer((KCSG ST14-05): CATALYSIS

Is NCT01917552 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies capecitabine for gastric cancer.

Phase 3RecruitingAsan Medical CenterNCT01917552Data as of May 2026

Treatment: capecitabine — multi-center, prospective, randomized, open-label phase III

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Extracted eligibility criteria

Cancer type

Gastric Cancer

Disease stage

Required: Stage IB

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: chemotherapy

Previous chemotherapy or radiotherapy for the currently treated gastric cancer

Cannot have received: radiation therapy

Previous chemotherapy or radiotherapy for the currently treated gastric cancer

Lab requirements

Blood counts

ANC >1,500/uL, Platelets 100,000/uL, and Hb > 8.0 g/dL

Kidney function

serum creatinine < 1.5 mg/dL

Liver function

bilirubin < 1.5 mg/dL, ALT and AST < 3 times upper limit of normal

Cardiac function

No clinically significant (i.e. active) cardiac disease: e.g. unstable angina, symptomatic coronary artery disease, NYHA grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 6 months

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); Clinically significant (i.e. active) cardiac disease: e.g. unstable angina, symptomatic coronary artery disease, NYHA grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 6 months [excluded]

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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