Overview

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

Status:
Recruiting
Trial end date:
2026-08-01
Target enrollment:
0
Participant gender:
All
Summary
multi-center, prospective, randomized, open-label phase III
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Asan Medical Center
Collaborators:
Ajou University School of Medicine
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Gachon University Gil Medical Center
Gangnam Severance Hospital
Hallym University Medical Center
Inje University
Kangbuk Samsung Hospital
Korea University Guro Hospital
Kyung Hee University Hospital
Kyungpook National University Hospital
Roche Pharma AG
Seoul National University Boramae Hospital
Seoul National University Bundang Hospital
Ulsan University Hospital
Treatments:
Capecitabine
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 practice
contraception during the study medication and until 3 months after discontinuation of
the study medication.

- Any evidence of metastatic disease (including presence of tumor cells in the ascites).

- Previous chemotherapy or radiotherapy for the currently treated gastric cancer.

- No recovery from serious complications of gastrectomy.

- History of another malignancy within the last five years except cured basal cell
carcinoma of skin and cured carcinoma in-situ of uterine cervix.

- History of uncontrolled seizures, central nervous system disorders or psychiatric
disability judged by the investigator to be clinically significant precluding informed
consent or interfering with compliance for oral drug intake.

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

- Lack of physical integrity of the upper gastrointestinal tract or those who have
malabsorption syndrome likely to influence absorption of capecitabine, or inability to
take oral medication.

- Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant
disease.

- Organ allografts requiring immunosuppressive therapy.

- Received any investigational drug or agent/procedure, i.e. participation in another
trial within 4 weeks before randomization.

- Requirement for concurrent use of the antiviral agent sorivudine (antiviral) or
chemically related analogues, such as brivudine.

- Positive serologic test for HIV