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

This study is currently recruiting participants.
Verified December 2010 by Seoul National University Hospital
Sponsor:
Collaborator:
Seoul National University Bundang Hospital
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01111591
First received: March 31, 2009
Last updated: December 14, 2010
Last verified: December 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Bile Duct Cancer
Pancreatic Cancer
 Drug: Cox2 inhibitor (Celecoxib)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Open-label, Controlled Trial of Cyclooxygenase-2 Inhibitor (Celecoxib; Celebrex®) for Adjuvant Anticancer Effect in Patients With Biliary-pancreas Cancer.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • short term outcome [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    recurrent rate and survival rate


Secondary Outcome Measures:
  • Long term outcome (survival rate, recurrence rate) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 220
Study Start Date: November 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1. Bile duct cancer - experimental
Patients with extrahepatic bile duct cancer with administration of COX2 inhibitor
 Drug: Cox2 inhibitor (Celecoxib)
From postoperative third day, administration will be started celecoxib 200mg bid for 6 months for administration group.
Other Name: Celebrex
2. Bile duct cancer - control
Extrahepatic bile duct cancer patients - control group
 Drug: Cox2 inhibitor (Celecoxib)
From postoperative third day, administration will be started celecoxib 200mg bid for 6 months for administration group.
Other Name: Celebrex
3. Pancreas cancer - experimental
Pancreas cancer patients - COX2 administration group
 Drug: Cox2 inhibitor (Celecoxib)
From postoperative third day, administration will be started celecoxib 200mg bid for 6 months for administration group.
Other Name: Celebrex
4. Pancreas cancer - control
Pancreas cancer patients - control group
 Drug: Cox2 inhibitor (Celecoxib)
From postoperative third day, administration will be started celecoxib 200mg bid for 6 months for administration group.
Other Name: Celebrex

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

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01111591

Contacts
Contact: Ho-Seong Han, Professor 82-31-787-7091 hanhs@snubh.org
Contact: Keun Soo Ahn, Doctor 82-31-787-6152 krince@gmail.com

Locations
Korea, Republic of
Ho-Seong Han Recruiting
Seonnam City, Gyeon gi do, Korea, Republic of, 463-707
Contact: Ho-Seong Han, professor     82-31-787-7091     hanhs@snubh.org    
Contact: Keun Soo Ahn, doctor     82-31-787-6152     krince@gmail.com    
Sponsors and Collaborators
Seoul National University Hospital
Seoul National University Bundang Hospital
Investigators
Study Chair: Ho-Seong Han, Professor General surgery department
  More Information

Publications:

Responsible Party: Seoul National University Bundang hospital, General Surgery department
ClinicalTrials.gov Identifier: NCT01111591     History of Changes
Other Study ID Numbers: SNUBH-GS-HBP2, B-0712-052-006 (local IRB)
Study First Received: March 31, 2009
Last Updated: December 14, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
Cyclooxygenase-2 inhibitor (Celecoxib)
Extrahepatic bile duct cancer
Pancreas cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Bile Duct Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Biliary Tract Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Pancreatin
Pancrelipase
Celecoxib
 Cyclooxygenase 2 Inhibitors
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013