Overview
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).
Eligibility
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