Cyclooxygenase-2 Inhibitor For Adjuvant Anticancer Effect In Patients With Biliary-pancreas Cancer

Study Overview

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

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

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

Bile Duct Cancer
Pancreatic Cancer

DRUG: Cox2 inhibitor (Celecoxib)

SNUBH-GS-HBP2
B-0712-052-006 (local IRB) (OTHER Identifier) (OTHER: Seoul National University Bundang Hospital)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2009-03-31	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-10-27
First Submitted that Met QC Criteria 2010-04-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-10-28
First Posted (ESTIMATED) 2010-04-27	Results First Posted N/A	Last Verified 2016-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
NO_INTERVENTION: 2. Bile duct cancer - control Bile duct cancer patients do not administration of COX inhibitor
EXPERIMENTAL: 3. Pancreas cancer - experimental Pancreas cancer patients take a COX2 inhibitor 200mg every 12hours for 6 months	DRUG: Cox2 inhibitor (Celecoxib) From postoperative third day, administration will be started celecoxib 200mg bid for 6 months for administration group.
NO_INTERVENTION: 4. Pancreas cancer - control Pancreas cancer patients do not administration of COX inhibitor
EXPERIMENTAL: Bile duct cancer - experimental Bile duct cancer patients take a COX2 inhibitor 200mg every 12hours for 6 months	DRUG: Cox2 inhibitor (Celecoxib) From postoperative third day, administration will be started celecoxib 200mg bid for 6 months for administration group.

Primary Outcome Measures	Measure Description	Time Frame
Short term outcome	Recurrent rate and survival rate	2 years

Secondary Outcome Measures	Measure Description	Time Frame
Long term outcome	Recurrent rate and survival rate	4 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
19 Years

Accepts Healthy Volunteers:

The patients who underwent operation for extrahepatic bile duct cancer or pancreas cancer
Between 19 and 70 years old
Agreed to consent sheet

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Seoul National University Bundang Hospital

Investigators

STUDY_CHAIR: Ho-Seong Han, Professor, General surgery department

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

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