Unresectable Biliary Tract CancerPhase 2NCT01127555
Salvage mFOLFOX in BTC After Failure of Gemcitabine
A Phase 2 study testing 5-fluorouracil, leucovorin, oxaliplatin in people with Unresectable Biliary Tract Cancer, run by Chung-Ang University at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of mFOLFOX (5-fluorouracil, leucovorin, oxaliplatin)as salvage therapy in patients with unresectable biliary tract cancer who had failed gemcitabine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Biliary Tract Cancer
- What is being tested?
- 5-fluorouracil, leucovorin, oxaliplatin
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2010to Jan 2013
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age : older than 18
- Histologically confirmed adenocarcinoma of the biliary tract
- Metastatic or unresectable biliary cancer
- Prior exposure to gemcitabine chemotherapy for biliary cancer
- Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
- A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in spiral Computed Tomography (CT) or multidetector CT
- Adequate bone marrow, liver, renal function
Who cannot join
- Pregnancy and breast-feeding.
- Other serious illness or medical condition, notably heart or lung failure, active uncontrolled infection (infection requiring antibiotics).
- Past or concurrent history of other neoplasm, except curatively treated basal cell skin cancer or adequately treated in-situ carcinoma of the cervix.
- Symptomatic or uncontrolled brain metastasis
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chung-Ang University Yongsan Hospital
Yongsan, Seoul, 140-757
About this study
Official title: Phase II Study of Salvage mFOLFOX(5-fluorouracil, Leucovorin, Oxaliplatin) in Patients With Unresectable Biliary Tract Cancer (BTC) Who Had Failed Gemcitabine
The purpose of this study is to evaluate the efficacy and safety of mFOLFOX (5-fluorouracil, leucovorin, oxaliplatin)as salvage therapy in patients with unresectable biliary tract cancer who had failed gemcitabine.
- Conditions
- Unresectable Biliary Tract Cancer
- Being tested
- 5-fluorouracil, leucovorin, oxaliplatin
- Keywords
- Biliary Tract Cancer, Salvage therapy, FOLFOX
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-fluorouracil, leucovorin, oxaliplatinDrug
Also called mFOLFOX
D1 Oxaliplatin 85mg/m2 D1, 2 LV 30mg/m2 IV push D1, 2 5-FU 1500mg/m2 CIV over 24hrs Every 2 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Clinically assessed every cycle (2weeks) and radiologically assessed every 3 cycles (6 weeks) with CT scan
Measured: 1 year
Secondary outcomes (3)
To evaluate the safety
Clinically assessed every cycle (2weeks)
Measured: 1 year
To estimate the time to progression
Measured: 1 year
To estimate overall survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Biliary Tract CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung-Ang University
- Sponsor type
- University, hospital or other
- Collaborators
- Gyeongsang National University Hospital, Dong-A University Hospital, Samsung Medical Center
- Responsible party
- Principal investigator, In Gyu Hwang, Chung-Ang University
- Investigators
- In Gyu Hwang, M.D., Study director, Chung-Ang University Yongsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127555
- Sponsor's protocol ID
- CAUHHO 2010-2
- Status last verified
- Oct 2013
- First submitted
- 5 May 2010
- Last updated
- 8 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Salvage mFOLFOX(5-fluorouracil, Leucovorin, Oxaliplatin) in Patients With Unresectable Biliary Tract Cancer (BTC) Who Had Failed Gemcitabine
- ClinicalTrials.gov ID
- NCT01127555
- Acronym / sponsor ID
- CAUHHO 2010-2
- Conditions
- Unresectable Biliary Tract Cancer
- Keywords
- Biliary Tract Cancer, Salvage therapy, FOLFOX
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chung-Ang UniversityUniversity, hospital or other
- Collaborators
- Gyeongsang National University Hospital, Dong-A University Hospital, Samsung Medical Center
- Study start
- Apr 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 21 May 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.
The purpose of this study is to evaluate the efficacy and safety of mFOLFOX (5-fluorouracil, leucovorin, oxaliplatin)as salvage therapy in patients with unresectable biliary tract cancer who had failed gemcitabine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age : older than 18
- Histologically confirmed adenocarcinoma of the biliary tract
- Metastatic or unresectable biliary cancer
- Prior exposure to gemcitabine chemotherapy for biliary cancer
- Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
Key exclusion criteria (4 listed)
- Pregnancy and breast-feeding.
- Other serious illness or medical condition, notably heart or lung failure, active uncontrolled infection (infection requiring antibiotics).
- Past or concurrent history of other neoplasm, except curatively treated basal cell skin cancer or adequately treated in-situ carcinoma of the cervix.
- Symptomatic or uncontrolled brain metastasis
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 |
|---|---|---|
| 5-fluorouracil, leucovorin, oxaliplatinAlso: mFOLFOXD1 Oxaliplatin 85mg/m2 D1, 2 LV 30mg/m2 IV push D1, 2 5-FU 1500mg/m2 CIV over 24hrs Every 2 weeks | Drug | – |
Primary outcome
Response rate
Time frame: 1 year
Clinically assessed every cycle (2weeks) and radiologically assessed every 3 cycles (6 weeks) with CT scan
3 secondary outcomes
To evaluate the safety
Time frame: 1 year
To estimate the time to progression
Time frame: 1 year
To estimate overall survival
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2013.
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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.
In Gyu Hwang, M.D. study director
Chung-Ang University Yongsan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5-fluorouracil, leucovorin, oxaliplatin in people with Unresectable Biliary Tract Cancer, run by Chung-Ang University 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 7 inclusion and 4 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: finished, as of the sponsor's last update on 8 Oct 2013. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Response rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2013.