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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Seoul National University Hospital
Sponsor:
Collaborator:
Seoul National University Bundang Hospital
Information provided by (Responsible Party):
Ho-Seong Han, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01111591
First received: March 31, 2009
Last updated: December 4, 2013
Last verified: December 2013

March 31, 2009
December 4, 2013
November 2008
December 2013   (final data collection date for primary outcome measure)
short term outcome [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
recurrent rate and survival rate
Same as current
Complete list of historical versions of study NCT01111591 on ClinicalTrials.gov Archive Site
Long term outcome (survival rate, recurrence rate) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Cyclooxygenase-2 Inhibitor for Adjuvant Anticancer Effect in Patients With Biliary-pancreas Cancer
Prospective, Randomized, Open-label, Controlled Trial of Cyclooxygenase-2 Inhibitor (Celecoxib; Celebrex®) 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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Bile Duct Cancer
  • Pancreatic Cancer
Drug: Cox2 inhibitor (Celecoxib)
From postoperative third day, administration will be started celecoxib 200mg bid for 6 months for administration group.
Other Name: Celebrex
  • 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
    Intervention: Drug: Cox2 inhibitor (Celecoxib)
  • 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
    Intervention: Drug: Cox2 inhibitor (Celecoxib)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
220
December 2015
December 2013   (final data collection date for primary outcome measure)

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
Both
19 Years to 70 Years
No
Contact: Ho-Seong Han, Professor 82-31-787-7091 hanhs@snubh.org
Contact: Young Ki Kim, Doctor 82-31-787-6882 ykkim@snubh.org
Korea, Republic of
 
NCT01111591
SNUBH-GS-HBP2, B-0712-052-006 (local IRB)
Yes
Ho-Seong Han, Seoul National University Hospital
Seoul National University Hospital
Seoul National University Bundang Hospital
Study Chair: Ho-Seong Han, Professor General surgery department
Seoul National University Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP