Brief Title
Cyclooxygenase-2 Inhibitor for Adjuvant Anticancer Effect in Patients With Biliary-pancreas Cancer
Official Title
Prospective, Randomized, Open-label, Controlled Trial of Cyclooxygenase-2 Inhibitor (Celecoxib; Celebrex®) for Adjuvant Anticancer Effect in Patients With Biliary-pancreas Cancer.
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
- 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
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Short term outcome
Secondary Outcome
Long term outcome
Condition
Bile Duct Cancer
Intervention
Cox2 inhibitor (Celecoxib)
Study Arms / Comparison Groups
2. Bile duct cancer - control
Description: Bile duct cancer patients do not administration of COX inhibitor
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
220
Start Date
November 2008
Completion Date
June 2017
Primary Completion Date
June 2017
Eligibility Criteria
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
Gender
All
Ages
19 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
Ho-Seong Han, Professor, ,
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT01111591
Organization ID
SNUBH-GS-HBP2
Secondary IDs
B-0712-052-006 (local IRB)
Responsible Party
Principal Investigator
Study Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital
Study Sponsor
Ho-Seong Han, Professor, Study Chair, General surgery department
Verification Date
October 2016