KCT0001298招募中未知
Phase III Study of Adjuvant Capecitabine vs Observation Alone in Curatively Resected Stage IB (by AJCC 6th Edition) Gastric Cancer(KCSG ST14-05)
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 870
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 74(Year)（—）
- 性别
- All
入选标准
- •?Curatively resected gastric or gastroesophageal junction adenocarcinoma
- •?Pathologic stage IB (by AJCC 6th edition) with at least one additional risk factor for recurrence
- •?Age: 18 -74years
- •?Eastern Cooperative Oncology Group(ECOG) performance status: 0-2
- •?Adequate bone marrow function (absolute neutrophil count >1,500/uL, Platelets ? 100,000/uL, and Hemoglobin > 8.0 g/dL)
- •?Adequate renal function (serum creatinine < 1.5 mg/dL)
- •?Adequate hepatic function (bilirubin < 1.5 mg/dL, alanine transaminase and aspartate transaminase < 3 times upper limit of normal)
- •?Written informed consent
排除标准
- •?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 human immunodeficiency virus(HIV)
研究者
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