Bile Duct CancerPhase 4NCT01111591
Cyclooxygenase-2 Inhibitor for Adjuvant Anticancer Effect in Patients With Biliary-pancreas Cancer
A Phase 4 study testing Cox2 inhibitor (Celecoxib) in people with Bile Duct Cancer and Pancreatic Cancer, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
In extrahepatic bile duct cancer and pancreatic cancer, we will treat postoperatively with COX2 inhibitor and assess survival rate and recurrent rate. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Bile Duct Cancer, Pancreatic Cancer
- What is being tested?
- Cox2 inhibitor (Celecoxib)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2008to Jun 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients who underwent operation for extrahepatic bile duct cancer or pancreas cancer
- Between 19 and 70 years old
- Agreed to consent sheet
Who cannot join
- 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
Show all 10Show fewer
- Preexisting Asthma. Especially aspirin-sensitive asthma.
- Contraindications to aspirin, clopidogrel or celecoxib
- When patients refused
- Patients has psychological problem
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Bile Duct Cancer, Pancreatic Cancer
- Being tested
- Cox2 inhibitor (Celecoxib)
- Keywords
- Cyclooxygenase-2 inhibitor (Celecoxib), Extrahepatic bile duct cancer, Pancreas cancer
- Medical subject headings
- Bile Duct Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cox2 inhibitor (Celecoxib)Drug
Also called Celebrex
From postoperative third day, administration will be started celecoxib 200mg bid for 6 months for administration group.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Cox2 inhibitor (Celecoxib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short term outcome
Recurrent rate and survival rate
Measured: 2 years
Secondary outcomes (1)
Long term outcome
Recurrent rate and survival rate
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2010 (estimated)
- Study startNov 2008
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bile Duct CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Responsible party
- Principal investigator, Ho-Seong Han, Seoul National University Hospital
- Investigators
- Ho-Seong Han, Professor, Study chair, General surgery department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01111591
- Sponsor's protocol ID
- SNUBH-GS-HBP2
- Other IDs
- B-0712-052-006 (local IRB)
- Status last verified
- Oct 2016
- First submitted
- 31 Mar 2009
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 17707751
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Open-label, Controlled Trial of Cyclooxygenase-2 Inhibitor (Celecoxib; Celebrex®) for Adjuvant Anticancer Effect in Patients With Biliary-pancreas Cancer.
- ClinicalTrials.gov ID
- NCT01111591
- Acronym / sponsor ID
- SNUBH-GS-HBP2
- Conditions
- Bile Duct Cancer, Pancreatic Cancer
- Keywords
- Cyclooxygenase-2 inhibitor (Celecoxib), Extrahepatic bile duct cancer, Pancreas cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Study start
- Nov 2008
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 27 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2. Bile duct cancer - control | No intervention | –Bile duct cancer patients do not administration of COX inhibitor |
| 3. Pancreas cancer - experimental | Experimental | Drug: Cox2 inhibitor (Celecoxib)Pancreas cancer patients take a COX2 inhibitor 200mg every 12hours for 6 months |
| 4. Pancreas cancer - control | No intervention | –Pancreas cancer patients do not administration of COX inhibitor |
| Bile duct cancer - experimental | Experimental | Drug: Cox2 inhibitor (Celecoxib)Bile duct cancer patients take a COX2 inhibitor 200mg every 12hours for 6 months |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patients who underwent operation for extrahepatic bile duct cancer or pancreas cancer
- Between 19 and 70 years old
- Agreed to consent sheet
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cox2 inhibitor (Celecoxib)Also: CelebrexFrom postoperative third day, administration will be started celecoxib 200mg bid for 6 months for administration group. | Drug | 3. Pancreas cancer - experimental, Bile duct cancer - experimental |
Primary outcome
Short term outcome
Time frame: 2 years
Recurrent rate and survival rate
1 secondary outcome
Long term outcome
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
- Results publication: PubMed 17707751Koo 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ho-Seong Han, Professor study chair
General surgery department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cox2 inhibitor (Celecoxib) in people with Bile Duct Cancer and Pancreatic Cancer, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short term outcome (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01111591, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2016.