NCT01917552 Adjuvant Capecitabine Versus Observation Alone in Curatively Resected Stage IB Gastric Cancer((KCSG ST14-05): CATALYSIS
| NCT ID | NCT01917552 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Asan Medical Center |
| Condition | Gastric Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 870 participants |
| Start Date | 2013-08-19 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 870 participants in total. It began in 2013-08-19 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
multi-center, prospective, randomized, open-label phase III
Eligibility 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
Contact & Investigator
Min-Hee Ryu, MD, PhD
PRINCIPAL INVESTIGATOR
Asan Medical Center
Frequently Asked Questions
Who can join the NCT01917552 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 74 Years, studying Gastric Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT01917552 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 870 participants.
Is NCT01917552 currently recruiting?
Yes, NCT01917552 is actively recruiting participants. Contact the research team at miniryu@amc.seoul.kr for enrollment information.
Where is the NCT01917552 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT01917552 clinical trial?
NCT01917552 is sponsored by Asan Medical Center. The principal investigator is Min-Hee Ryu, MD, PhD at Asan Medical Center. The trial plans to enroll 870 participants.
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