Clinical trial NCT01111591: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bile Duct Cancer
Pancreatic Cancer
Keywords: Cyclooxygenase-2 inhibitor (Celecoxib)
Extrahepatic bile duct cancer
Pancreas cancer
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
First posted: 2010-04-27
Enrollment: 220
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Short term outcome
timeFrame: 2 years
Secondary outcomes:
measure: Long term outcome
timeFrame: 4 years
Other outcomes:
Locations:
city: Seonnam City
country: Korea, Republic of
facility: Ho-Seong Han
state: Gyeon gi do
Study officials:
affiliation: General surgery department
name: Ho-Seong Han, Professor
role: STUDY_CHAIR
References:
citation: 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): an open-label randomised controlled study. Lancet. 2007 Aug 18;370(9587):567-74. doi: 10.1016/S0140-6736(07)61295-1.