Status:
RECRUITING
Adjuvant Capecitabine Versus Observation Alone in Curatively Resected Stage IB Gastric Cancer((KCSG ST14-05): CATALYSIS
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Ulsan University Hospital
Seoul National University Bundang Hospital
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-74 years
Phase:
PHASE3
Brief Summary
multi-center, prospective, randomized, open-label phase III
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 19 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
870 Patients enrolled
Trial Details
Trial ID
NCT01917552
Start Date
August 19 2013
End Date
August 1 2026
Last Update
February 28 2024
Active Locations (1)
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1
Asan Medical Center
Seoul, Songpa-gu, South Korea, 138-736