Pancreatic Cancer Clinical Trial
Official title:
Prospective, Randomized, Open-label, Controlled Trial of Cyclooxygenase-2 Inhibitor (Celecoxib; Celebrex®) for Adjuvant Anticancer Effect in Patients With Biliary-pancreas Cancer.
In extrahepatic bile duct cancer and pancreatic cancer, we will treat postoperatively with COX2 inhibitor and assess survival rate and recurrent rate.
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
- Impossible of administration due to severe postoperative morbidities (bleeding, bowel
obstruction, pancreatic fistula, biliary fistula)
- 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
- The patients who refuse trial
- The patients who has Psychogenic problem
Allocation
- We will allocate patients randomly, to administration group or control group
Methods
- From postoperative third day, administration will be started
- celecoxib 200mg bid for 6 months for administration group
- Follow up and assess recurrence rate and survival rate
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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