NCT01111591

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2009

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

April 27, 2010

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

October 28, 2016

Status Verified

October 1, 2016

Enrollment Period

8.6 years

First QC Date

March 31, 2009

Last Update Submit

October 27, 2016

Conditions

Bile Duct CancerPancreatic Cancer

Keywords

Cyclooxygenase-2 inhibitor (Celecoxib)Extrahepatic bile duct cancerPancreas cancer

Outcome Measures

Primary Outcomes (1)

  • Short term outcome

    Recurrent rate and survival rate

    2 years

Secondary Outcomes (1)

  • Long term outcome

    4 years

Study Arms (4)

2. Bile duct cancer - control

NO INTERVENTION

Bile duct cancer patients do not administration of COX inhibitor

3. Pancreas cancer - experimental

EXPERIMENTAL

Pancreas cancer patients take a COX2 inhibitor 200mg every 12hours for 6 months

Drug: Cox2 inhibitor (Celecoxib)

4. Pancreas cancer - control

NO INTERVENTION

Pancreas cancer patients do not administration of COX inhibitor

Bile duct cancer - experimental

EXPERIMENTAL

Bile duct cancer patients take a COX2 inhibitor 200mg every 12hours for 6 months

Drug: Cox2 inhibitor (Celecoxib)

Interventions

Cox2 inhibitor (Celecoxib)DRUG

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

Also known as: Celebrex
3. Pancreas cancer - experimentalBile duct cancer - experimental

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients who underwent operation for extrahepatic bile duct cancer or pancreas cancer
  • Between 19 and 70 years old
  • Agreed to consent sheet

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ho-Seong Han

Seonnam City, Gyeon Gi Do, 463-707, South Korea

Location

Related Publications (1)

  • Koo BK, Kim YS, Park KW, Yang HM, Kwon DA, Chung JW, Hahn JY, Lee HY, Park JS, Kang HJ, Cho YS, Youn TJ, Chung WY, Chae IH, Choi DJ, Oh BH, Park YB, Kim HS. Effect of celecoxib on restenosis after coronary angioplasty with a Taxus stent (COREA-TAXUS trial): an open-label randomised controlled study. Lancet. 2007 Aug 18;370(9587):567-74. doi: 10.1016/S0140-6736(07)61295-1.

    PMID: 17707751RESULT

MeSH Terms

Conditions

Bile Duct NeoplasmsPancreatic Neoplasms

Interventions

Cyclooxygenase 2 InhibitorsCelecoxib

Condition Hierarchy (Ancestors)

Biliary Tract NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Cyclooxygenase InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesAnti-Inflammatory Agents, Non-SteroidalAnalgesics, Non-NarcoticAnalgesicsSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsAnti-Inflammatory AgentsTherapeutic UsesAntirheumatic AgentsBenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Ho-Seong Han, Professor

    General surgery department

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 31, 2009

First Posted

April 27, 2010

Study Start

November 1, 2008

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

October 28, 2016

Record last verified: 2016-10

Locations

KR(1)