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

Phase 4

• Conditions: Bile Duct Cancer; Pancreatic Cancer
• Interventions: Drug: Cox2 inhibitor (Celecoxib)

• Registration Number: NCT01111591
• Lead Sponsor: Seoul National University Hospital

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 Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-03-31
• Study First Submitted QC: 2010-04-26
• Study First Posted: 2010-04-27
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-28
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3. Pancreas cancer - experimental	Cox2 inhibitor (Celecoxib)	Pancreas cancer patients take a COX2 inhibitor 200mg every 12hours for 6 months
Bile duct cancer - experimental	Cox2 inhibitor (Celecoxib)	Bile duct cancer patients take a COX2 inhibitor 200mg every 12hours for 6 months

Primary Outcome Measures

Name	Time	Method
Short term outcome	2 years	Recurrent rate and survival rate

Secondary Outcome Measures

Name	Time	Method
Long term outcome	4 years	Recurrent rate and survival rate

Trial Locations

Locations (1)

Ho-Seong Han; 🇰🇷 Seonnam City, Gyeon gi do, Korea, Republic of