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