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

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IVTreatmentActive19 to 70OtherSNUBH-GS-HBP2
B-0712-052-006 (local IRB), NCT01111591

Trial Description

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 Contact Information

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

Republic of Korea

Seonnam City

Ho-Seong Han

Ho-Seong Han, professor
Ph: 82-31-787-7091
Email: hanhs@snubh.org

Yujin Kwon, doctor
Ph: 82-31-787-6157
Email: nesia7979@gmail.com

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01111591
ClinicalTrials.gov processed this data on January 29, 2015

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.