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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01111591

Enrollment

220

Registered

2010-04-27

Start date

2008-11-30

Completion date

2017-06-30

Last updated

2016-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bile Duct Cancer, Pancreatic Cancer

Keywords

Cyclooxygenase-2 inhibitor (Celecoxib), Extrahepatic bile duct cancer, Pancreas cancer

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

Interventions

DRUGCox2 inhibitor (Celecoxib)

From postoperative third day, administration will be started celecoxib 200mg bid for 6 months for administration group.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Short term outcome	2 years	Recurrent rate and survival rate

Secondary

Measure	Time frame	Description
Long term outcome	4 years	Recurrent rate and survival rate

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026