KCT0006098招募中未知
A randomized phase 3 clinical trial investigating optimal duration of oxaliplatin administration in postoperative XELOX (oxaliplatin + capecitabine) adjuvant chemotherapy for the patients with stage II/III gastric cancer
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 1,069
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
- 19(Year) 至 0No Limit（—）
- 性别
- All
入选标准
- •? Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma patients who underwent curative surgery (D1 beta or D2 resection)
- •? Pathologically confirmed stage II, III patients (AJCC 8th edition)
- •? Age 19 years and older
- •? Eastern Cooperative Oncology Group (ECOG) performance status 0 or 2
- •? Adequate marrow function (ANC > 1,500/uL, Platelet >100,000/uL, Hb > 8.0 g/dL, patients with chronic anemia who require intermittent blood transfusions can also participate in the study)
- •? Adequate renal function, with serum creatinine < 1.5 x upper limit of normal (ULN).
- •? Adequate hepatic function with serum total bilirubin = 1.5 x ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3 x ULN
- •? Written, informed consent to the study
排除标准
- •? Female patients who are pregnant or breast-feeding
- •? Positive pregnancy test at baseline (postmenopausal women should be amenorrhea for at least 12 months to be considered non-fertile)
- •? Sexually active men and women who are not willing to implement contraception during study and until 3 months after discontinuation of study drug
- •? Evidence of metastasis (including cytologically confirmed malignant ascites)
- •? Prior systemic chemotherapy or radiation therapy for stomach cancer
- •? Patients who have not recovered from serious complications of gastrectomy
- •? History of other malignancies within the last 3 years (excluding adequately treated basal cell carcinoma of the skin, in situ cancer of the cervix, non-metastatic thyroid cancer)
- •? A history of clinically significant uncontrolled seizures, central nervous system disorders, or mental disorders, which make it impossible to understand the informed consent or interfere with compliance with oral drug intake
- •? Clinically significant (i.e., active) heart disease: e.g. unstable angina requiring medication, symptomatic coronary artery disease, congestive heart failure with NYHA grade II or higher, severe cardiac arrhythmias or acute coronary syndrome in the past 6 months (including myocardial infarction)
- •? Lack of integrity or malabsorption syndrome in the upper gastrointestinal tract, which is likely to affect the absorption of study drug
- •? Serious uncontrolled infection or other serious uncontrolled disease
- •? History of allograft requiring immunosuppression therapy
- •? Received any investigational drug or procedure within 4 weeks prior to randomization
- •? Active viral infection (for hepatitis B carrier, patients can be registered if HBV-DNA titer is less than 20,000 IU/mL, and are allowed to use prophylactic antiviral agents by investigator’s choice)
- •? Active HIV infection
- •? Patients with peripheral sensory neuropathy with functional impairment
研究者
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