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

October 27, 2016 updated by: Ho-Seong Han, Seoul National University Hospital

Prospective, Randomized, Open-label, Controlled Trial of Cyclooxygenase-2 Inhibitor (Celecoxib; Celebrex®) for Adjuvant Anticancer Effect in Patients With Biliary-pancreas Cancer.

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeon gi do
      • Seonnam City, Gyeon gi do, Korea, Republic of, 463-707
        • Ho-Seong Han

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 2. Bile duct cancer - control
Bile duct cancer patients do not administration of COX inhibitor
Experimental: 3. Pancreas cancer - experimental
Pancreas cancer patients take a COX2 inhibitor 200mg every 12hours for 6 months
Drug: Cox2 inhibitor (Celecoxib)
From postoperative third day, administration will be started celecoxib 200mg bid for 6 months for administration group.
Other Names:
  • Celebrex
No Intervention: 4. Pancreas cancer - control
Pancreas cancer patients do not administration of COX inhibitor
Experimental: Bile duct cancer - experimental
Bile duct cancer patients take a COX2 inhibitor 200mg every 12hours for 6 months
Drug: Cox2 inhibitor (Celecoxib)
From postoperative third day, administration will be started celecoxib 200mg bid for 6 months for administration group.
Other Names:
  • Celebrex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short term outcome
Time Frame: 2 years
Recurrent rate and survival rate
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long term outcome
Time Frame: 4 years
Recurrent rate and survival rate
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Seoul National University Bundang Hospital

Investigators

  • Study Chair: Ho-Seong Han, Professor, General surgery department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

March 31, 2009

First Submitted That Met QC Criteria

April 26, 2010

First Posted (Estimate)

April 27, 2010

Study Record Updates

Last Update Posted (Estimate)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUBH-GS-HBP2
  • B-0712-052-006 (local IRB) (Other Identifier: Seoul National University Bundang Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Cancer

Clinical Trials on Cox2 inhibitor (Celecoxib)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe