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


Phase 4
19 Years
70 Years
Open (Enrolling)
Both
Bile Duct Cancer, Pancreatic Cancer

Thank you

Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

short term outcome

Outcome Description:

recurrent rate and survival rate

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Ho-Seong Han, Professor

Investigator Role:

Study Chair

Investigator Affiliation:

General surgery department

Authority:

Korea: Food and Drug Administration

Study ID:

SNUBH-GS-HBP2

NCT ID:

NCT01111591

Start Date:

November 2008

Completion Date:

December 2015

Related Keywords:

  • Bile Duct Cancer
  • Pancreatic Cancer
  • Cyclooxygenase-2 inhibitor (Celecoxib)
  • Extrahepatic bile duct cancer
  • Pancreas cancer
  • Pancreatic Neoplasms
  • Bile Duct Neoplasms

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