NCT01111591Unknown4 期
Prospective, Randomized, Open-label, Controlled Trial of Cyclooxygenase-2 Inhibitor (Celecoxib; Celebrex®) for Adjuvant Anticancer Effect in Patients With Biliary-pancreas Cancer.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Short term outcome
研究概览
简要总结
In extrahepatic bile duct cancer and pancreatic cancer, we will treat postoperatively with COX2 inhibitor and assess survival rate and recurrent rate.
详细描述
Patients : total 220 patients
- Extrahepatic bile duct cancer : 55 patients for administration of COX2 55 patients for control group
- Pancreas cancer : 55 patients for administration of COX2 55 patients for control group
Indication
- After operation of extrahepatic bile duct cancer or pancreas cancer
- Age : 19 - 70 years old
- The patients who agree to consent sheet.
Contraindication
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
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients who underwent operation for extrahepatic bile duct cancer or pancreas cancer
- •Between 19 and 70 years old
- •Agreed to consent sheet
排除标准
- •The patients cannot administration of drug due to severe postoperative morbidities.
- •Preexisting heart disease: Ischemic heart disease, Heart failure. Severe uncontrolled hypertension (systolic BP>160)
- •Renal insufficiency: CCR < 50 or serum creatinin >3.0
- •Hepatic insufficiency: Liver cirrhosis or active hepatitis
- •Preexisting allergic reaction history for NSAIDs or Sulfonamide
- •Current drug intake: Warfarin. Lithium, Fluconazole, Aspirin, Celecoxib
- •Preexisting Asthma. Especially aspirin-sensitive asthma.
- •Contraindications to aspirin, clopidogrel or celecoxib
- •When patients refused
- •Patients has psychological problem
研究组 & 干预措施
3. Pancreas cancer - experimental
Experimental
Pancreas cancer patients take a COX2 inhibitor 200mg every 12hours for 6 months
干预措施: Cox2 inhibitor (Celecoxib) (Drug)
Bile duct cancer - experimental
Experimental
Bile duct cancer patients take a COX2 inhibitor 200mg every 12hours for 6 months
干预措施: Cox2 inhibitor (Celecoxib) (Drug)
结局指标
主要结局
Short term outcome
时间窗: 2 years
Recurrent rate and survival rate
次要结局
- Long term outcome(4 years)
研究者
Ho-Seong Han
Professor
Seoul National University Hospital
研究点 (1)
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