NCT01470742撤回3 期
A Randomized, Phase III, Multicenter Clinical Trial Comparing Capecitabine Plus Oxaliplatin (XELOX) and Capecitabine (X) as First-line Chemotherapy in Elderly Patients With Advanced Gastric Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Overall survival of XELOX(XELODA/oxaliplatin) vs X(XELODA)
研究概览
简要总结
The objective of the trial is to compare Overall survival between capecitabine plus oxaliplatin (XELOX) and capecitabine (X) as first-line chemotherapy in elderly patients with advanced gastric cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed adenocarcinoma of the gastric
- •Advanced ,metastatic/recurrence gastric cancer
- •ECOG performance status of 0 to 2
- •Life expectancy≥3months
- •No history of any systemic anti-cancer chemotherapy (prior adjuvant chemoradiation or chemotherapy is allowed if the last date of drug administration is > 6months from the study entry date)
- •No history of radiation therapy about Target lesion. (Prior radiotherapy is permitted if it was not administered to target lesions selected for this study, unless progression of the selected target lesions within the radiation portal is documented, and provided it has been completed at least 4 weeks before randomization.
- •Adequate marrow functions (ANC ≥ 1,500/uL, PLT ≥100,000/uL)
- •Adequate renal functions (Creatinine ≤1.5mg/dL or Ccr ≥ 50ml/min)
- •Adequate hepatic functions ( bilirubin ≤ 2.0mg/dL, SGOT/SGPT < normal x 3)
- •provision of a signed written informed consent
排除标准
- •History of any medical or psychiatric condition
- •Active infections
- •Peripheral neuropathy with symptom(NCI-CTCAE ver. 3.0 >=Grade 1 )
- •symptomatic brain metastases
- •Double primary cancer (physician at the discretion of the other cancer cured the purpose of early cancer cases can be registered)
- •History of other malignancy except:
- •Adequately treated non-melanomatous skin cancer or cervical carcinoma in situ
- •Known hypersensitivity to Fluoropyrimidines/platinum
- •Clinical significant cardiovascular disease (myocardial infarction, symptomatic coronary artery disease, congestive heart failure, severe arrhythmias)
- •Required immunosuppressive therapy(transplant patients, severe autoimmune disease)
研究组 & 干预措施
XELODA
Active Comparator
Capecitabine 1000mg/m2 bid D1-14 every 3weeks
干预措施: XELODA (Drug)
XELOX
Experimental
D1-14 Capecitabine 1000mg/m2 bid D1 Oxaliplatin 110mg/m2 + D5W 250ml over 2hr every 3weeks
干预措施: XELOX (Drug)
结局指标
主要结局
Overall survival of XELOX(XELODA/oxaliplatin) vs X(XELODA)
时间窗: 36months
次要结局
- response rate(36months)
研究者
Won Ki Kang
Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology
Samsung Medical Center
研究点 (1)
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