Biliary Tract CancerPhase 2NCT02350686
XELOX in Advanced Biliary Tract Carcinoma After Failure of Gemcitabine-based Chemotherapy
A Phase 2 study testing capecitabine and oxaliplatin in people with Biliary Tract Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Phase II study of second line capecitabine plus oxaliplatin (XELOX) in patients with advanced biliary tract carcinoma after failure of gemcitabine-based chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Cancer
- What is being tested?
- capecitabine and oxaliplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 May 2015to Dec 2020
- 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 ≥ 18
- histologically or cytologically confirmed adenocarcinoma of biliary tract (intrahepatic, extrahepatic cholangiocarcinoma, gall bladder cancer and ampulla of Vater cancer)
- unresectable or metastatic
- progression after treatment with first line gemcitabine-based chemotherapy
- ECOG performance status of 0~2
- measurable or evaluable lesion per RECIST 1.1 criteria
- adequate marrow, hepatic, renal and cardiac functions
Who cannot join
- severe co-morbid illness or active infections
- pregnant or lactating women
- History of documented congestive heart failure, angina pectoris requiring medication, evidence of tranasmural myocardial infarction on ECG, poorly controlled hypertension, clinically significant valvular heart disease or high risk of uncontrollable arrhythmia
- active CNS metastases not controllable with radiotherapy or corticosteroids
- known history of hypersensitivity to study drugs
Trial locations and contacts
1 site in 1 country.
hoyeong lim, MD,Ph contact
sungju park contact
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
sungju park, sungju6820.park@samsung.com
About this study
Official title: Phase II Study of Second Line Capecitabine Plus Oxaliplatin (XELOX) in Patients With Advanced Biliary Tract Carcinoma After Failure of Gemcitabine-based Chemotherapy
Phase II study of second line capecitabine plus oxaliplatin (XELOX) in patients with advanced biliary tract carcinoma after failure of gemcitabine-based chemotherapy.
Read the detailed description
XELOX
- Xeloda, 1000mg/㎡ bid, day 1-15, every 3 weeks
- Oxaliplatin 130mg/㎡, day 1, every 3 weeks Until disease progression, patient's refusal or up to 8 cycles (maximum).
- Conditions
- Biliary Tract Cancer
- Being tested
- capecitabine, oxaliplatin
- 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.
capecitabineDrug
Also called xeloda
XELOX every 3 weeks will be continued until disease progression, patients' refusal or upto 8 cycles
oxaliplatinDrug
XELOX every 3 weeks will be continued until disease progression, patients' refusal or upto 8 cycles
| Study group | Role | What they receive |
|---|---|---|
| capecitabine+oxaliplatin | Experimental | XELOX every 3 weeks Receives: Drug: capecitabine; Drug: oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: 12months
Secondary outcomes (4)
response rate
Measured: 12months
duration of response
Measured: 12months
overall survival
Measured: 12months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study start14 May 2015
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho Yeong Lim, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02350686
- Sponsor's protocol ID
- 2014-09-020
- Status last verified
- May 2019
- First submitted
- 24 Nov 2014
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Second Line Capecitabine Plus Oxaliplatin (XELOX) in Patients With Advanced Biliary Tract Carcinoma After Failure of Gemcitabine-based Chemotherapy
- ClinicalTrials.gov ID
- NCT02350686
- Acronym / sponsor ID
- 2014-09-020
- Conditions
- Biliary Tract Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 14 May 2015 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 30 Jan 2015 (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.
Phase II study of second line capecitabine plus oxaliplatin (XELOX) in patients with advanced biliary tract carcinoma after failure of gemcitabine-based chemotherapy.
Detailed description
XELOX
- Xeloda, 1000mg/㎡ bid, day 1-15, every 3 weeks
- Oxaliplatin 130mg/㎡, day 1, every 3 weeks Until disease progression, patient's refusal or up to 8 cycles (maximum).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| capecitabine+oxaliplatin | Experimental | Drug: capecitabine, Drug: oxaliplatinXELOX every 3 weeks |
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 ≥ 18
- histologically or cytologically confirmed adenocarcinoma of biliary tract (intrahepatic, extrahepatic cholangiocarcinoma, gall bladder cancer and ampulla of Vater cancer)
- unresectable or metastatic
- progression after treatment with first line gemcitabine-based chemotherapy
- ECOG performance status of 0~2
Key exclusion criteria (5 listed)
- severe co-morbid illness or active infections
- pregnant or lactating women
- History of documented congestive heart failure, angina pectoris requiring medication, evidence of tranasmural myocardial infarction on ECG, poorly controlled hypertension, clinically significant valvular heart disease or high risk of uncontrollable arrhythmia
- active CNS metastases not controllable with radiotherapy or corticosteroids
- known history of hypersensitivity to study drugs
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 |
|---|---|---|
| capecitabineAlso: xelodaXELOX every 3 weeks will be continued until disease progression, patients' refusal or upto 8 cycles | Drug | capecitabine+oxaliplatin |
| oxaliplatinXELOX every 3 weeks will be continued until disease progression, patients' refusal or upto 8 cycles | Drug | capecitabine+oxaliplatin |
Primary outcome
Progression-free survival
Time frame: 12months
4 secondary outcomes
response rate
Time frame: 12months
duration of response
Time frame: 12months
overall survival
Time frame: 12months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 24months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
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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.
hoyeong lim, MD,Ph contact
sungju park contact
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 capecitabine and oxaliplatin in people with Biliary Tract Cancer, run by Samsung Medical Center 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 5 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 20 May 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hoyeong lim, MD,Ph (hoy.lim@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 12months). 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 20 May 2019.