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

Primary Purpose

Bile Duct Cancer, Pancreatic Cancer

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cox2 inhibitor (Celecoxib)
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bile Duct Cancer focused on measuring Cyclooxygenase-2 inhibitor (Celecoxib), Extrahepatic bile duct cancer, Pancreas cancer

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ho-Seong Han

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

No Intervention

Experimental

Arm Label

2. Bile duct cancer - control

3. Pancreas cancer - experimental

4. Pancreas cancer - control

Bile duct cancer - experimental

Arm Description

Bile duct cancer patients do not administration of COX inhibitor

Pancreas cancer patients take a COX2 inhibitor 200mg every 12hours for 6 months

Pancreas cancer patients do not administration of COX inhibitor

Bile duct cancer patients take a COX2 inhibitor 200mg every 12hours for 6 months

Outcomes

Primary Outcome Measures

Short term outcome
Recurrent rate and survival rate

Secondary Outcome Measures

Long term outcome
Recurrent rate and survival rate

Full Information

First Posted
March 31, 2009
Last Updated
October 27, 2016
Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01111591
Brief Title
Cyclooxygenase-2 Inhibitor for Adjuvant Anticancer Effect in Patients With Biliary-pancreas Cancer
Official Title
Prospective, Randomized, Open-label, Controlled Trial of Cyclooxygenase-2 Inhibitor (Celecoxib; Celebrex®) for Adjuvant Anticancer Effect in Patients With Biliary-pancreas Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2008 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bile Duct Cancer, Pancreatic Cancer
Keywords
Cyclooxygenase-2 inhibitor (Celecoxib), Extrahepatic bile duct cancer, Pancreas cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2. Bile duct cancer - control
Arm Type
No Intervention
Arm Description
Bile duct cancer patients do not administration of COX inhibitor
Arm Title
3. Pancreas cancer - experimental
Arm Type
Experimental
Arm Description
Pancreas cancer patients take a COX2 inhibitor 200mg every 12hours for 6 months
Arm Title
4. Pancreas cancer - control
Arm Type
No Intervention
Arm Description
Pancreas cancer patients do not administration of COX inhibitor
Arm Title
Bile duct cancer - experimental
Arm Type
Experimental
Arm Description
Bile duct cancer patients take a COX2 inhibitor 200mg every 12hours for 6 months
Intervention Type
Drug
Intervention Name(s)
Cox2 inhibitor (Celecoxib)
Other Intervention Name(s)
Celebrex
Intervention Description
From postoperative third day, administration will be started celecoxib 200mg bid for 6 months for administration group.
Primary Outcome Measure Information:
Title
Short term outcome
Description
Recurrent rate and survival rate
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Long term outcome
Description
Recurrent rate and survival rate
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ho-Seong Han, Professor
Organizational Affiliation
General surgery department
Official's Role
Study Chair
Facility Information:
Facility Name
Ho-Seong Han
City
Seonnam City
State/Province
Gyeon gi do
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
17707751
Citation
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. Erratum In: Lancet. 2007 Sep 14;370(9590):828.
Results Reference
result

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

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