NCT01953406

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 1, 2013

Completed
2.1 years until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

April 27, 2016

Status Verified

April 1, 2016

Enrollment Period

Same day

First QC Date

September 21, 2013

Last Update Submit

April 26, 2016

Conditions

Hepatocellular CarcinomaLung Metastasis

Keywords

hepatocellular carcinomalung metastasis5-fluorouracil/mitomycin

Outcome Measures

Primary Outcomes (1)

  • Time-to-progression(TTP)of lung metastasis

    every 12 weeks, up to 36 weeks

Secondary Outcomes (5)

  • Overall survival

    every 12 weeks, up to 36 weeks

  • Response rates(CR + PR)of lung metastasis

    every 12 weeks, up to 36 weeks

  • progression free survival

    every 12 weeks, up to 36 weeks

  • Time to recurrence of intrahepatic tumor

    every 12 weeks, up to 36 weeks

  • Disease control rates (CR + PR + SD)of lung metastasis

    every 12 weeks, up to 36 weeks

Other Outcomes (1)

  • Adverse Events

    every 12 weeks, up to 36 weeks

Study Arms (1)

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

Drug: 5-fluorouracilDrug: Mitomycin

Interventions

5-fluorouracilDRUG

5-fluorouracin 15mg/kg/day D1-6 civ till progression, every 4 weeks

Also known as: 5-FU
The 5-fluorouracil/mitomycin group
MitomycinDRUG

Mitomycin 4mg/day iv push D1,4 till progression, every 4 weeks

The 5-fluorouracil/mitomycin group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

FluorouracilMitomycin

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMitomycinsIndolequinonesQuinonesOrganic ChemicalsAzirinesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Jung-Hwan Yoon, M.D., Ph.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 21, 2013

First Posted

October 1, 2013

Study Start

November 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

April 27, 2016

Record last verified: 2016-04

Locations

KR(1)