Actively Recruiting
Adjuvant Capecitabine Versus Observation Alone in Curatively Resected Stage IB Gastric Cancer((KCSG ST14-05): CATALYSIS
Led by Asan Medical Center · Updated on 2024-02-28
870
Participants Needed
1
Research Sites
675 weeks
Total Duration
On this page
Sponsors
A
Asan Medical Center
Lead Sponsor
U
Ulsan University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
multi-center, prospective, randomized, open-label phase III
CONDITIONS
Official Title
Adjuvant Capecitabine Versus Observation Alone in Curatively Resected Stage IB Gastric Cancer((KCSG ST14-05): CATALYSIS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Curatively resected gastric or gastroesophageal junction adenocarcinoma
- Pathologic stage IB (by AJCC 6th edition) with at least one additional risk factor for recurrence (age >65 years, male gender, lymphovascular invasion, perineural invasion)
- Age between 18 and 74 years
- ECOG performance status of 0 to 2
- Adequate bone marrow function (ANC >1,500/uL, Platelets >100,000/uL, Hemoglobin >8.0 g/dL)
- Adequate renal function (serum creatinine <1.5 mg/dL)
- Adequate liver function (bilirubin <1.5 mg/dL, ALT and AST less than 3 times upper limit of normal)
- Provided written informed consent
You will not qualify if you...
- Pregnant or lactating women
- Women of childbearing potential with a positive pregnancy test at baseline
- Postmenopausal women must have been amenorrheic for at least 12 months
- Sexually active males and females unwilling to use contraception during and for 3 months after study medication
- Evidence of metastatic disease including tumor cells in ascites
- Previous chemotherapy or radiotherapy for current gastric cancer
- No recovery from serious complications of gastrectomy
- History of another cancer within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
- History of uncontrolled seizures, CNS disorders, or psychiatric disability interfering with consent or compliance
- Active significant cardiac disease or recent myocardial infarction within 6 months
- Lack of physical integrity of upper GI tract or malabsorption affecting capecitabine absorption
- Serious uncontrolled infections or other serious uncontrolled diseases
- Organ transplants requiring immunosuppressive therapy
- Participation in another trial within 4 weeks before randomization
- Concurrent use of antiviral sorivudine or related drugs
- Positive HIV serologic test
AI-Screening
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Trial Site Locations
Total: 1 location
1
Asan Medical Center
Seoul, Songpa-gu, South Korea, 138-736
Actively Recruiting
Research Team
M
Min-Hee Ryu, MD, PhD
CONTACT
H
Hyung-Don Kim, M.D.,Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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