Hepatocellular CarcinomaPhase 2NCT01953406
The Efficacy of 5-fluorouracil/Mitomycin for the Patients With Pulmonary Metastasis of Hepatocellular Carcinoma
A Phase 2 study testing 5-fluorouracil and Mitomycin in people with Hepatocellular Carcinoma and Lung Metastasis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The aim of this study is to evaluate the efficacy of 5-fluorouracil + Mitomycin for the patients with pulmonary metastasis of hepatocellular carcinoma who had progressive disease with sorafenib. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma, Lung Metastasis
- What is being tested?
- 5-fluorouracil and Mitomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2015to Nov 2015
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have received previous local therapy treatments for the intrahepatic hepatocellular carcinoma (RFA, PEI, cryoablation, surgery, resection) and who don't have any viable intrahepatic tumor within 3 months of imaging (dynamic liver CT or liver MRI) after the locoregional therapy
- Patients who have measurable lung metastasis
- Patients who have received their last dose of sorafenib more than 14 days before and who had progressive disease of lung metastasis with sorafenib
- Patients who have risk factors of hepatocellular carcinoma (chronic hepatitis B, chronic hepatitis C, liver cirrhosis)
- Age : 18 years to 80 years
- ECOG Performance Status of 0 to 2
Show all 14Show fewer
- Child-Pugh class A,B (Child-Pugh score 5-9)
- Adequate bone marrow, liver function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
- WBC count > 1,000/mm3
- Absolute neutrophil count > 500/mm3
- Hb > 7.0 g/dL
- Platelet count > 50,000 /mm3
- Bilirubin < 3 mg/dL
- Adequate clotting function: INR < 2.3 or < 6sec
Who cannot join
- Child-Pugh score > 10
- ECOG Performance Status > 3
- History of organ allograft
- Patients with uncontrolled co-morbidity which needs treatment
- Patients who have received prior systemic chemotherapy except sorafenib
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study Evaluating the Efficacy of 5-fluorouracil/Mitomycin for the Patients With Pulmonary Metastasis of Hepatocellular Carcinoma Who Had Progressive Disease With Sorafenib
The aim of this study is to evaluate the efficacy of 5-fluorouracil + Mitomycin for the patients with pulmonary metastasis of hepatocellular carcinoma who had progressive disease with sorafenib.
Read the detailed description
Extrahepatic metastasis of hepatocellular carcinoma has recently been paradoxically increasing due to increased survival with effective locoregional therapies. Sorafenib is the first systemic agent that has demonstrated a significant survival benefit in patients with advanced HCC; however, the modest improvement of 3 months is far from satisfactory. There is no convincing evidence, to date, that systemic chemotherapy when tumor progresses after sorafenib therapy improves overall survival. The combination of anticancer agents is important to achieve favourable clinical results. For patients with metastatic liver cancer or HCC, some studies have discussed the effectiveness of 5-fluorouracil/mitomycin(FM). However, few studies have examined the actual FM regimen for HCC.
The aim of this study is to evaluate the efficacy of 5-fluorouracil/mitomycin for the patients with pulmonary metastasis of hepatocellular carcinoma who had progressive disease with sorafenib.
- Conditions
- Hepatocellular Carcinoma, Lung Metastasis
- Being tested
- 5-fluorouracil, Mitomycin
- Keywords
- hepatocellular carcinoma, lung metastasis, 5-fluorouracil/mitomycin
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-fluorouracilDrug
Also called 5-FU
5-fluorouracin 15mg/kg/day D1-6 civ till progression, every 4 weeks
MitomycinDrug
Mitomycin 4mg/day iv push D1,4 till progression, every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| The 5-fluorouracil/mitomycin group | Experimental | Systemic chemotherapy with 5-fluorouracil/mitomycin 5-fluorouracin 15mg/kg/day D1-6 civ + Mitomycin 4mg/day iv push D1,4 till progression, every 4 weeks Receives: Drug: 5-fluorouracil; Drug: Mitomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-to-progression(TTP)of lung metastasis
Measured: every 12 weeks, up to 36 weeks
Secondary outcomes (5)
Overall survival
Measured: every 12 weeks, up to 36 weeks
Response rates(CR + PR)of lung metastasis
Measured: every 12 weeks, up to 36 weeks
progression free survival
Measured: every 12 weeks, up to 36 weeks
Time to recurrence of intrahepatic tumor
Measured: every 12 weeks, up to 36 weeks
Disease control rates (CR + PR + SD)of lung metastasis
Measured: every 12 weeks, up to 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startNov 2015
- Primary completionNov 2015
- Study completionNov 2015
Why it stopped: No participants were enrolled. Therefore, we stop this study, prematurely.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung-Hwan Yoon, Seoul National University Hospital
- Investigators
- Jung-Hwan Yoon, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953406
- Sponsor's protocol ID
- LUNG M_FM
- Status last verified
- Apr 2016
- First submitted
- 21 Sep 2013
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Evaluating the Efficacy of 5-fluorouracil/Mitomycin for the Patients With Pulmonary Metastasis of Hepatocellular Carcinoma Who Had Progressive Disease With Sorafenib
- ClinicalTrials.gov ID
- NCT01953406
- Acronym / sponsor ID
- LUNG M_FM
- Conditions
- Hepatocellular Carcinoma, Lung Metastasis
- Keywords
- hepatocellular carcinoma, lung metastasis, 5-fluorouracil/mitomycin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants were enrolled. Therefore, we stop this study, prematurely.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 1 Oct 2013 (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 aim of this study is to evaluate the efficacy of 5-fluorouracil + Mitomycin for the patients with pulmonary metastasis of hepatocellular carcinoma who had progressive disease with sorafenib.
Detailed description
Extrahepatic metastasis of hepatocellular carcinoma has recently been paradoxically increasing due to increased survival with effective locoregional therapies. Sorafenib is the first systemic agent that has demonstrated a significant survival benefit in patients with advanced HCC; however, the modest improvement of 3 months is far from satisfactory. There is no convincing evidence, to date, that systemic chemotherapy when tumor progresses after sorafenib therapy improves overall survival. The combination of anticancer agents is important to achieve favourable clinical results. For patients with metastatic liver cancer or HCC, some studies have discussed the effectiveness of 5-fluorouracil/mitomycin(FM). However, few studies have examined the actual FM regimen for HCC.
The aim of this study is to evaluate the efficacy of 5-fluorouracil/mitomycin for the patients with pulmonary metastasis of hepatocellular carcinoma who had progressive disease with sorafenib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The 5-fluorouracil/mitomycin group | Experimental | Drug: 5-fluorouracil, Drug: MitomycinSystemic chemotherapy with 5-fluorouracil/mitomycin 5-fluorouracin 15mg/kg/day D1-6 civ + Mitomycin 4mg/day iv push D1,4 till progression, every 4 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients who have received previous local therapy treatments for the intrahepatic hepatocellular carcinoma (RFA, PEI, cryoablation, surgery, resection) and who don't have any viable intrahepatic tumor within 3 months of imaging (dynamic liver CT or liver MRI) after the locoregional therapy
- Patients who have measurable lung metastasis
- Patients who have received their last dose of sorafenib more than 14 days before and who had progressive disease of lung metastasis with sorafenib
- Patients who have risk factors of hepatocellular carcinoma (chronic hepatitis B, chronic hepatitis C, liver cirrhosis)
- Age : 18 years to 80 years
Key exclusion criteria (5 listed)
- Child-Pugh score > 10
- ECOG Performance Status > 3
- History of organ allograft
- Patients with uncontrolled co-morbidity which needs treatment
- Patients who have received prior systemic chemotherapy except sorafenib
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-fluorouracilAlso: 5-FU5-fluorouracin 15mg/kg/day D1-6 civ till progression, every 4 weeks | Drug | The 5-fluorouracil/mitomycin group |
| MitomycinMitomycin 4mg/day iv push D1,4 till progression, every 4 weeks | Drug | The 5-fluorouracil/mitomycin group |
Primary outcome
Time-to-progression(TTP)of lung metastasis
Time frame: every 12 weeks, up to 36 weeks
5 secondary outcomes
Overall survival
Time frame: every 12 weeks, up to 36 weeks
Response rates(CR + PR)of lung metastasis
Time frame: every 12 weeks, up to 36 weeks
progression free survival
Time frame: every 12 weeks, up to 36 weeks
Time to recurrence of intrahepatic tumor
Time frame: every 12 weeks, up to 36 weeks
Disease control rates (CR + PR + SD)of lung metastasis
Time frame: every 12 weeks, up to 36 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
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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.
Jung-Hwan Yoon, M.D., Ph.D. principal investigator
Seoul National University 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 and Mitomycin in people with Hepatocellular Carcinoma and Lung Metastasis, 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 14 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: withdrawn, as of the sponsor's last update on 27 Apr 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Time-to-progression(TTP)of lung metastasis (time frame: every 12 weeks, up to 36 weeks). 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 27 Apr 2016.