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.
Verified date | October 2016 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | Interventional |
In extrahepatic bile duct cancer and pancreatic cancer, we will treat postoperatively with COX2 inhibitor and assess survival rate and recurrent rate.
Status | Enrolling by invitation |
Enrollment | 220 |
Est. completion date | June 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 19 Years to 70 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Ho-Seong Han | Seonnam City | Gyeon gi do |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital | Seoul National University Bundang Hospital |
Korea, Republic of,
Koo BK, Kim YS, Park KW, Yang HM, Kwon DA, Chung JW, Hahn JY, Lee HY, Park JS, Kang HJ, Cho YS, Youn TJ, Chung WY, Chae IH, Choi DJ, Oh BH, Park YB, Kim HS. Effect of celecoxib on restenosis after coronary angioplasty with a Taxus stent (COREA-TAXUS trial — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Short term outcome | Recurrent rate and survival rate | 2 years | Yes |
Secondary | Long term outcome | Recurrent rate and survival rate | 4 years | Yes |
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