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

STATUS

Recruiting
End date

Aug 1, 2026
participants needed

870
sponsor

Asan Medical Center

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Updated on 24 January 2022

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renal function

capecitabine

adenocarcinoma of the gastroesophageal junction

adenocarcinoma

immunostimulants

Summary

multi-center, prospective, randomized, open-label phase III

Description

This is a prospective, randomized, open-label phase III study of adjuvant chemotherapy after curative resection in patients with pathologic stage IB (by AJCC 6th edition) gastric cancer with at least one additional risk factor (additional risk factors for recurrence include age >65 years, male gender, presence of lymphovascular invasion, presence of perineural invasion). The superiority design will compare the efficacy and safety profiles of adjuvant capecitabine (Arm A) versus observation alone (Arm B).

Details

Condition	Gastric Cancer
Treatment	Capecitabine
Clinical Study Identifier	NCT01917552
Sponsor	Asan Medical Center
Last Modified on	24 January 2022

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Eligibility		Yes	No	Not Sure
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

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