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The Efficacy of 5-fluorouracil/Mitomycin for the Patients With Pulmonary Metastasis of Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma, Lung Metastasis

Status

Withdrawn

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

5-fluorouracil

Mitomycin

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring hepatocellular carcinoma, lung metastasis, 5-fluorouracil/mitomycin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

The 5-fluorouracil/mitomycin group

Arm Description

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

Outcomes

Primary Outcome Measures

Time-to-progression(TTP)of lung metastasis

Secondary Outcome Measures

Overall survival

Response rates(CR + PR)of lung metastasis

progression free survival

Time to recurrence of intrahepatic tumor

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

Full Information

NCT ID

NCT01953406

First Posted

September 21, 2013

Last Updated

April 26, 2016

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01953406

Brief Title

The Efficacy of 5-fluorouracil/Mitomycin for the Patients With Pulmonary Metastasis of Hepatocellular Carcinoma

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Withdrawn

Why Stopped

No participants were enrolled. Therefore, we stop this study, prematurely.

Study Start Date

November 2015 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma, Lung Metastasis

Keywords

hepatocellular carcinoma, lung metastasis, 5-fluorouracil/mitomycin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

The 5-fluorouracil/mitomycin group

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

5-fluorouracil

Other Intervention Name(s)

5-FU

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Mitomycin

Intervention Description

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

Primary Outcome Measure Information:

Title

Time-to-progression(TTP)of lung metastasis

Time Frame