Biliary Cancer MetastaticPhase 2NCT03464968
mFOLFOX vs. mFOLFIRI in Advanced or Recurrent Biliary Tract Cancer Refractory to First Line
A Phase 2 study testing Oxaliplatin,5FU, leucovorin and irinotecan,5FU, leucovorin in people with Biliary Cancer Metastatic, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
In second line with advanced or recurrent biliary tract cancer refractory to first line gemcitabine plus cisplatin, efficacy of mFOLFOX vs. mFOLFIRI will be evaluated at randomized phase 2 trial. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Biliary Cancer Metastatic
- What is being tested?
- Oxaliplatin,5FU, leucovorin and irinotecan,5FU, leucovorin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Jul 2015to 25 Jul 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20 years and older
- pathologically confirmed biliary tract cancer (adenocarcinoma) including intrahepatic, extrahepatic, gallbladder, ampulla of vater
- initially inoperable or recurrent
- ECOG 0-2
- as first line chemotherapy, refractory to gemcitabine/cisplatin (at least one cycle applied)
- evaluable or measurable lesion
- within 1 week, patients who meet below laboratory results (hemoglobin >9.0 g/dL, neutrophil >1000/uL, platelet> 75000/uL, serum creatinine < UNL * 1.5, AST/ALT < UNL*3, total bilirubin < UNL*1.5 (available for biliary drainage)
- patients who have ability to understand the purpose, benefit and harm for this trial, and the right to withdraw this trial in any time without any disadvantage
Who cannot join
- other cancer history
- pregnant or lactating
- uncontrolled medical condition such as infection or cardiovascular disease
- hypersensitivity to experimental drugs
- uncontrolled CNS metastasis, psychologic problem
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: A Randomized Phase II Study of mFOLFOX vs. mFOLFIRI in Advanced or Recurrent Biliary Tract Cancer Refractory to First Line Gemcitabine Plus Cisplatin
In second line with advanced or recurrent biliary tract cancer refractory to first line gemcitabine plus cisplatin, efficacy of mFOLFOX vs. mFOLFIRI will be evaluated at randomized phase 2 trial.
Read the detailed description
- brief enrollment criteria
- histological confirmed
- refractory to first line gemcitabine plus cisplatin
- fit for chemotherapy
- treatment arms A. mFOLFOX D1 oxaliplatin 100mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks
- mFOLFIRI D1 Irinotecan 150mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks
- randomization - stratified by tumor site and performance status
- Conditions
- Biliary Cancer Metastatic
- Being tested
- Oxaliplatin,5FU, leucovorin, irinotecan,5FU, leucovorin
- Keywords
- second line, FOLFOX, FOLFIRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxaliplatin,5FU, leucovorinDrug
mFOLFOX
irinotecan,5FU, leucovorinDrug
mFOLFIRI
| Study group | Role | What they receive |
|---|---|---|
| mFOLFOX | Experimental | D1 oxaliplatin 100mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks Receives: Drug: Oxaliplatin,5FU, leucovorin |
| mFOLFIRI | Experimental | D1 Irinotecan 150mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks Receives: Drug: irinotecan,5FU, leucovorin |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 months overall survival rate
at 6 months from intervention treatment, overall survival rate
Measured: 6months
Secondary outcomes (4)
response rate
complete response, partial response
Measured: 6months
disease control rate
complete response, partial response, stable disease
Measured: 6months
progression free survival
from treatment start to progression or any cause of death
Measured: 6months
Number of Participants With Treatment-Related Adverse Events as Assessed by NCI CTC version 4.0
percentage of all patients
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start29 Jul 2015
- Primary completion10 Feb 2020
- Study completion25 Jul 2020
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 Biliary Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Won Kim, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464968
- Sponsor's protocol ID
- biliary second line
- Status last verified
- Dec 2020
- First submitted
- 1 Mar 2018
- Last updated
- 2 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choi IS, Kim KH, Lee JH, Suh KJ, Kim JW, Park JH, Kim YJ, Kim JS, Kim JH, Kim JW. A randomised phase II study of oxaliplatin/5-FU (mFOLFOX) versus irinotecan/5-FU (mFOLFIRI) chemotherapy in locally advanced or metastatic biliary tract cancer refractory to first-line gemcitabine/cisplatin chemotherapy. Eur J Cancer. 2021 Sep;154:288-295. doi: 10.1016/j.ejca.2021.06.019. Epub 2021 Jul 22.
PubMed 34303267
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of mFOLFOX vs. mFOLFIRI in Advanced or Recurrent Biliary Tract Cancer Refractory to First Line Gemcitabine Plus Cisplatin
- ClinicalTrials.gov ID
- NCT03464968
- Acronym / sponsor ID
- biliary second line
- Conditions
- Biliary Cancer Metastatic
- Keywords
- second line, FOLFOX, FOLFIRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 29 Jul 2015 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 25 Jul 2020 (actual)
- First posted
- 14 Mar 2018 (actual)
- 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 second line with advanced or recurrent biliary tract cancer refractory to first line gemcitabine plus cisplatin, efficacy of mFOLFOX vs. mFOLFIRI will be evaluated at randomized phase 2 trial.
Detailed description
- brief enrollment criteria
- histological confirmed
- refractory to first line gemcitabine plus cisplatin
- fit for chemotherapy
- treatment arms A. mFOLFOX D1 oxaliplatin 100mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks
- mFOLFIRI D1 Irinotecan 150mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks
- randomization - stratified by tumor site and performance status
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mFOLFOX | Experimental | Drug: Oxaliplatin,5FU, leucovorinD1 oxaliplatin 100mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks |
| mFOLFIRI | Experimental | Drug: irinotecan,5FU, leucovorinD1 Irinotecan 150mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 20 years and older
- pathologically confirmed biliary tract cancer (adenocarcinoma) including intrahepatic, extrahepatic, gallbladder, ampulla of vater
- initially inoperable or recurrent
- ECOG 0-2
- as first line chemotherapy, refractory to gemcitabine/cisplatin (at least one cycle applied)
Key exclusion criteria (5 listed)
- other cancer history
- pregnant or lactating
- uncontrolled medical condition such as infection or cardiovascular disease
- hypersensitivity to experimental drugs
- uncontrolled CNS metastasis, psychologic problem
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 |
|---|---|---|
| Oxaliplatin,5FU, leucovorinmFOLFOX | Drug | mFOLFOX |
| irinotecan,5FU, leucovorinmFOLFIRI | Drug | mFOLFIRI |
Primary outcome
6 months overall survival rate
Time frame: 6months
at 6 months from intervention treatment, overall survival rate
4 secondary outcomes
response rate
Time frame: 6months
disease control rate
Time frame: 6months
progression free survival
Time frame: 6months
Number of Participants With Treatment-Related Adverse Events as Assessed by NCI CTC version 4.0
Time frame: 6months
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 2 Dec 2020.
- Derived from this study: PubMed 34303267Choi IS, Kim KH, Lee JH, Suh KJ, Kim JW, Park JH, Kim YJ, Kim JS, Kim JH, Kim JW. A randomised phase II study of oxaliplatin/5-FU (mFOLFOX) versus irinotecan/5-FU (mFOLFIRI) chemotherapy in locally advanced or metastatic biliary tract cancer refractory to first-line gemcitabine/cisplatin chemotherapy. Eur J Cancer. 2021 Sep;154:288-295. doi: 10.1016/j.ejca.2021.06.019. Epub 2021 Jul 22.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Oxaliplatin,5FU, leucovorin and irinotecan,5FU, leucovorin in people with Biliary Cancer Metastatic, run by Seoul National University Bundang 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 8 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: finished, as of the sponsor's last update on 2 Dec 2020. 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?
6 months overall survival rate (time frame: 6months). 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 NCT03464968, 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 2 Dec 2020.