NCT00152243已完成3 期
A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of UFT Compared With Surgery Alone for Serosa-negative Advanced Gastric Cancer (NSAS-GC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Overall survival and relapse-free survival
研究概览
简要总结
This is a controlled study designed to evaluate the efficacy of UFT on survival compared with surgery alone. Patients will be randomly assigned to receive either surgery alone or surgery followed by UFT within 6 weeks after curative resection. To assess treatment response, data on recurrence and survival will be collected for 5 years after enrollment of the last patient. To evaluate safety, data on adverse events will be collected for 16 months after the start of treatment.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20 to 75
- •Performance status 0 , 1, or 2 (ECOG)
- •Hematopoietic WBC ≥ 4,000/mm^3 Platelet ≥ 100,000/mm^3
- •Hepatic AST and ALT ≤ 2 times upper limit of normal(ULN) Total bilirubin ≤ 1.5 times ULN
- •Renal BUN ≤1.5 times ULN Creatinine ≤ 1.5 times ULN
排除标准
- •Prior anticancer treatment
研究组 & 干预措施
1
Experimental
UFT (uracil, tegafur)
干预措施: UFT (uracil, tegafur) (Drug)
2
Other
Surgery alone
干预措施: Surgery alone (Procedure)
结局指标
主要结局
Overall survival and relapse-free survival
时间窗: every course for first three courses, then every other course
次要结局
- Adverse events(any time)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A Randomized Controlled Study of Postoperative Adjuvant Therapy of Uracil-tegafur (UFT) Compared With Cyclophosphamide/Methotrexate/5-fluorouracil (CMF) in Breast Cancer (NSAS-BC)Breast CancerNCT00152191Taiho Pharmaceutical Co., Ltd.1,300
已完成
3 期
A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-CC)Colorectal CancerNCT00152230Taiho Pharmaceutical Co., Ltd.900
已完成
不适用
Enhanced Recovery After Surgery Protocal Versus Traditional Care in Laparoscopic HepatectomyLiver DiseasesNCT02533193Sir Run Run Shaw Hospital126
已完成
不适用
A Randomized-controlled Trial of Post-operative Opiate Quantities After Urogynecologic SurgeryPostoperative PainOpioid UseNCT03319277The Cleveland Clinic118
已完成
不适用
Rehabilitation Following Lumbar Disc SurgeryRadiculopathyLumbar Disc HerniationNCT00894972University of Utah60