Cyclooxygenase-2 Inhibitor for Adjuvant Anticancer Effect in Patients With Biliary-pancreas Cancer

Study Overview
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Brief Summary
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In extrahepatic bile duct cancer and pancreatic cancer, we will treat postoperatively with COX2 inhibitor and assess survival rate and recurrent rate.

Detailed Description
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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

Official Title
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Prospective, Randomized, Open-label, Controlled Trial of Cyclooxygenase-2 Inhibitor (Celecoxib; Celebrex®) for Adjuvant Anticancer Effect in Patients With Biliary-pancreas Cancer.

Conditions
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Bile Duct Cancer, Pancreatic Cancer

Intervention / Treatment
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* Drug: Cox2 inhibitor (Celecoxib)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 2. Bile duct cancer - control<br>Bile duct cancer patients do not administration of COX inhibitor | |
| Experimental: 3. Pancreas cancer - experimental<br>Pancreas cancer patients take a COX2 inhibitor 200mg every 12hours for 6 months | Drug: Cox2 inhibitor (Celecoxib)<br>* From postoperative third day, administration will be started celecoxib 200mg bid for 6 months for administration group.<br>* Other names: Celebrex;|
| No Intervention: 4. Pancreas cancer - control<br>Pancreas cancer patients do not administration of COX inhibitor | |
| Experimental: Bile duct cancer - experimental<br>Bile duct cancer patients take a COX2 inhibitor 200mg every 12hours for 6 months | Drug: Cox2 inhibitor (Celecoxib)<br>* From postoperative third day, administration will be started celecoxib 200mg bid for 6 months for administration group.<br>* Other names: Celebrex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short term outcome | Recurrent rate and survival rate | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term outcome | Recurrent rate and survival rate | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cyclooxygenase-2 inhibitor (Celecoxib), Extrahepatic bile duct cancer, Pancreas cancer