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

Pancreatic Cancer Clinical Trial

Official title:

Prospective, Randomized, Open-label, Controlled Trial of Cyclooxygenase-2 Inhibitor (Celecoxib; Celebrex®) for Adjuvant Anticancer Effect in Patients With Biliary-pancreas Cancer.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01111591
• Other study ID #: SNUBH-GS-HBP2
• Secondary ID: B-0712-052-006 (
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: March 31, 2009
• Last updated: October 27, 2016
• Start date: November 2008
• Est. completion date: June 2017

Study information

• Verified date: October 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 220
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bile Duct Cancer
• Bile Duct Neoplasms
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Cox2 inhibitor (Celecoxib)
From postoperative third day, administration will be started celecoxib 200mg bid for 6 months for administration group.

Locations

Country	Name	City	State
Korea, Republic of	Ho-Seong Han	Seonnam City	Gyeon gi do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short term outcome	Recurrent rate and survival rate	2 years	Yes
Secondary	Long term outcome	Recurrent rate and survival rate	4 years	Yes