Fluorouracil Implants（SinoFuan®）Used for Intraperitoneal Chemotherapy During Operation for Intraperitoneal Chemotherapy During Operation for Treatment of Phase III Gastric Cancer, Randomized, Controlled, Multicentres Open Study.
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- DFS (Disease Free Survival)
研究概览
简要总结
SinoFuan is a kind of Fluorouracil Implants for intraperitoneal chemotherapy during operation for treatment of gastric cancer. The indication has bee approved by Chinese FDA. The study is a post-marketing study. The subjects will be divided into two groups (Group A and Group B ). The subject in Group A will receive D2 radical gastrectomy(R0),Sinofuan during operation and 6 cycles of Xelox adjuvant chemotherapy.The subject in Group B will receive D2 radical gastrectomy(R0),and 6 cycles of Xelox adjuvant chemotherapy. The subject's benefits from SinoFuan will be analyzed through comparing 3 years DFS of two groups.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary gastric cancer, Phase III
- •D2 radical gastrectomy(R0)
- •18 year old or above
- •suitable hematologic function: ANC≥1.5×109/L, PLC≥80×109/L
- •suitable liver function: Total bilirubin≤1.5×normal ULN, AST and ALT≤2.5×normal ULN.
- •suitable renal function: Cr≤1.5×normal ULN,or Ccr≥50 ml/min 8 .for the female subject, pregnancy test must be negative in 27 hours before enrollment .
- •the authorized ICF must be signed
排除标准
- •non-initial gastric cancer；
- •having the other uncontrolled diseases.
- •obvious loss of weight ( more than 10% within 6 weeks )
- •the female in pregnancy or feeding.
- •contraindication to study drug
- •participating in other clinical trial and at the time of treatment period.
研究组 & 干预措施
Fluorouracil Implants and Xelox regimes
Fluorouracil Implants: 800mg, implanted in the abdominal cavity during operation.
Xelox regimes: Capecitabine,1000 mg/m2，PO.BID, from D1 to D14; Oxaliplatin, 130 mg/m2，IV, D1 in each cycle. The cycle will repeated every 21 days till 6 cycles finished.
干预措施: Fluorouracil Implants (Drug)
Fluorouracil Implants and Xelox regimes
Fluorouracil Implants: 800mg, implanted in the abdominal cavity during operation.
Xelox regimes: Capecitabine,1000 mg/m2，PO.BID, from D1 to D14; Oxaliplatin, 130 mg/m2，IV, D1 in each cycle. The cycle will repeated every 21 days till 6 cycles finished.
干预措施: Xelox regimes (Drug)
Xelox regimes
Xelox regimes: Capecitabine,1000 mg/m2，PO.BID, from D1 to D14; Oxaliplatin, 130 mg/m2，IV, D1 in each cycle. The cycle will repeated every 21 days till 6 cycles finished.
干预措施: Xelox regimes (Drug)
结局指标
主要结局
DFS (Disease Free Survival)
时间窗: 3 year
During 3 years of monitoring period, any cancer relapse will be recorded
次要结局
- adverse event(3 years)