NCT01364376已完成不适用
S-1 Plus Oxaliplatin Compared With Fluorouracil, Leucovorin Calcium Plus Oxaliplatin as Perioperative Chemotherapy for Advanced Gastric Carcinoma: a Multi-center, Open-labeled, Randomized Controlled Trial
Zhejiang University8 个研究点 分布在 1 个国家目标入组 583 人开始时间: 2011年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 583
- 试验地点
- 8
- 主要终点
- overall survival
研究概览
简要总结
This is a randomized multicenter controlled study of oxaliplatin, leucovorin calcium , plus 5-fluorouracil (FOLFOX) compared with S-1 plus oxaliplatin (SOX) as perioperative chemotherapy for advanced gastric cancer.
Hypothesis: SOX is not inferior to FOLFOX as perioperative chemotherapy for 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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed gastric adenocarcinoma,diagnosed as locally advanced gastric cancer and primary tumor invades or penetrates serosa
- •Ambulatory males or females, aged 18-80 years old
- •ECOG score 0-2
- •Given informed consent
- •Life expectancy more than 3 months
- •Measurable lesion
- •Normal cardiac, hepatic, renal, and bone marrow function(WBC:3.5×10^9/l~12×10^9/l;PLT:>100×109/l;Bil:<1.5 fold of upper limit value; ALT/AST:<2.5 fold of upper limit value;Ccr:>80ml/min;Cr:1.5mg/dl)
排除标准
- •Prior stomach surgery
- •Previous cytotoxic chemotherapy, radiotherapy, target therapy or immunotherapy for any tumor
- •History of another malignancy except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
- •distant metastasis(such as No.16 and No.13 lymphnode,liver, lung,brain,bones or peritoneal metastasis)
- •Severe bleeding
- •Bowel obstruction, ileus or complete pyloric obstruction
- •Serious uncontrolled concomitant disease
- •History of myocardial infarction in 6 months
- •Woman with on-going pregnancy or breast-feeding, or contemplating pregnancy
- •Systemic treatment with corticosteroid
- •Patients judged inappropriate for the trial by the physicians
研究组 & 干预措施
FOLFOX
Active Comparator
干预措施: S-1; Oxaliplatin; 5-Fu; Leucovorin Calcium (Drug)
SOX
Experimental
干预措施: S-1; Oxaliplatin; 5-Fu; Leucovorin Calcium (Drug)
结局指标
主要结局
overall survival
时间窗: 3-year
次要结局
- progression-free survival(PFS)(3-year)
- clinical response(6 or 12 weeks)
- pathological response(within 10 days after surgery)
- Number of Participants with grade 3/4 adverse Events(6 Years)
研究者
Jiren Yu
Chief doctor
Zhejiang University
研究点 (8)
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