NCT01111591UnknownPhase 4
Prospective, Randomized, Open-label, Controlled Trial of Cyclooxygenase-2 Inhibitor (Celecoxib; Celebrex®) for Adjuvant Anticancer Effect in Patients With Biliary-pancreas Cancer.
Seoul National University Hospital1 site in 1 country220 target enrollmentStarted: November 2008Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- Short term outcome
Study Overview
Brief Summary
In extrahepatic bile duct cancer and pancreatic cancer, we will treat postoperatively with COX2 inhibitor and assess survival rate and recurrent rate.
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The patients who underwent operation for extrahepatic bile duct cancer or pancreas cancer
- •Between 19 and 70 years old
- •Agreed to consent sheet
Exclusion Criteria
- •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
Arms & Interventions
3. Pancreas cancer - experimental
Experimental
Pancreas cancer patients take a COX2 inhibitor 200mg every 12hours for 6 months
Intervention: Cox2 inhibitor (Celecoxib) (Drug)
Bile duct cancer - experimental
Experimental
Bile duct cancer patients take a COX2 inhibitor 200mg every 12hours for 6 months
Intervention: Cox2 inhibitor (Celecoxib) (Drug)
Outcomes
Primary Outcomes
Short term outcome
Time Frame: 2 years
Recurrent rate and survival rate
Secondary Outcomes
- Long term outcome(4 years)
Investigators
Ho-Seong Han
Professor
Seoul National University Hospital
Study Sites (1)
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