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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 (Jun 2026). This Phase 3 trial studies capecitabine for gastric cancer.

Phase 3RecruitingAsan Medical CenterNCT01917552Data as of Jun 2026Location: South Korea

Treatment: capecitabinemulti-center, prospective, randomized, open-label phase III

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Extracted eligibility criteria

Treatments studied

Chemotherapy

capecitabine

Cancer type

Gastric Cancer

Disease stage

Required: Stage IB

Performance status

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

Demographics

Ages ≤ 74

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.

Frequently asked questions

Is NCT01917552 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

What disease stage is eligible?

Stage IB is required.

Is there an age limit?

Yes. Patients must be 74 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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