Cyclooxygenase-2 Inhibitor for Adjuvant Anticancer Effect in Patients With Biliary-pancreas Cancer
Trial Sites
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Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase IV | Treatment | Active | 19 to 70 | Other | SNUBH-GS-HBP2 B-0712-052-006 (local IRB), NCT01111591 |
Summary
In extrahepatic bile duct cancer and pancreatic cancer, we will treat postoperatively with COX2 inhibitor and assess survival rate and recurrent rate.
Further Study Information
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
Eligibility Criteria
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 Lead Organizations/Sponsors
Seoul National University Hospital
Seoul National University Bundang Hospital| Ho-Seong Han, Professor |  | Study Chair |
| Ho-Seong Han, Professor | | Ph: 82-31-787-7091 |
| Email: hanhs@snubh.org | ||
Trial Sites
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| Republic of Korea | |||
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| Seonnam City | |||
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| Ho-Seong Han | |||
| Ho-Seong Han, professor | Ph: 82-31-787-7091 | ||
| Email: hanhs@snubh.org | |||
| Keun Soo Ahn, doctor | Ph: 82-31-787-6152 | ||
| Email: krince@gmail.com | |||
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01111591
Information obtained from ClinicalTrials.gov on November 20, 2012
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
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