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

Seoul National University

Status and phase: Unknown; Phase 4

Conditions: Bile Duct Cancer; Pancreatic Cancer

Treatments: Drug: Cox2 inhibitor (Celecoxib)

Study type: Interventional

Funder types: Other

Identifiers

NCT01111591

SNUBH-GS-HBP2

B-0712-052-006 (local IRB) (Other Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment: 220 estimated patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 4 patient groups

2. Bile duct cancer - control

No Intervention group

Description:

Bile duct cancer patients do not administration of COX inhibitor

3. Pancreas cancer - experimental

Experimental group

Description:

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

Treatment:

Drug: Cox2 inhibitor (Celecoxib)

4. Pancreas cancer - control

No Intervention group

Description:

Pancreas cancer patients do not administration of COX inhibitor

Bile duct cancer - experimental

Experimental group

Description:

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

Treatment:

Drug: Cox2 inhibitor (Celecoxib)