NCT01111591

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.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Bile Duct Cancer
• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Cox2 inhibitor (Celecoxib)	From postoperative third day, administration will be started celecoxib 200mg bid for 6 months for administration group.

Timeline

• Start date: 2008-11-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2010-04-27
• Last updated: 2016-10-28

Locations

1 site across 1 country: South Korea