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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000487
Receipt No. R000000591
Scientific Title Phase I/II trial of hepatic arterial infusion of FMP therapy for advanced hepatocellular carcinoma
Date of disclosure of the study information 2006/09/12
Last modified on 2010/09/13

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Basic information
Public title Phase I/II trial of hepatic arterial infusion of FMP therapy for advanced hepatocellular carcinoma
Acronym Hepatic arterial infusion of FMP therapy for advanced hepatocellular carcinoma
Scientific Title Phase I/II trial of hepatic arterial infusion of FMP therapy for advanced hepatocellular carcinoma
Scientific Title:Acronym Hepatic arterial infusion of FMP therapy for advanced hepatocellular carcinoma
Region
Japan

Condition
Condition advanced hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the maximum-tolerated dose and the recommended dose based on the frequency of dose-limiting toxicities of continuous intraarterial infusion of 5-fluorouracil, mitoxantrone and cisplatin (FMP therapy) in a phase I, and to evaluate the efficacy and toxicity of FMP therapy at the recommended dose for advanced hepatocellular carcinoma in a phase II.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Phase I:
frequency of dose-limiting toxicities
Phase II:
response rate and adverse events at the recommended dose
Key secondary outcomes Progression free survival, overall survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 FMP therapy:
The therapy consists of intraarterial administration of cisplatin and mitoxantrone on day 1, and continuous intraarterial infusion of 5-fluorouracil on days 1 through 5. The treatment is repeated every four weeks for a maximum of six courses if there is no evidence of tumor progression or unacceptable toxicity.
Dosage level[5-fluorouracil, mitoxantrone, cisplatin (mg/m2)]
Level -1 [300, 4, 50]
Level 0 [300, 4, 60]
Level 1 [400, 4, 60]
Level 2 [400, 6, 60]
Level 3 [500, 6, 60]
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Advanced hepatocellular carcinoma with confirmation of histological examination or typical computed tomographic(CT), angiographic findings and elevated serum alpha-fetoprotein levels
2) No indication for surgical resection, local ablation, and transcatheter arterial embolization
3) Measurable disease
4) Aged 20 years or over
5) An Eastern Cooperative Oncology Group performance status of 0-2
6) A hepatic arterial catheter and port system placed and the adequate drug distribution confirmed by CT angiography or MR angiography
7) Sufficient organ function: WBC>=3,000 /mm3, Hb>=9.0 g/dL, PLT>=70,000 /mm3, Child-Pugh grade A or B, T-Bil<=2.0 mg/dL, Albumin>=3.0 g/dL, AST<=200 U/L, ALT<=200 U/L, Creatinine<=1.1 mg/dL, Creatinine clearance>= 60 ml/min
8) Interval of 4 weeks or over between last treatment and present therapy, and no influence of previous treatments
9) Written informed consent
Key exclusion criteria 1) Prior chemotherapy with 5-fluorouracil, mitoxantrone, and cisplatin for hepatocellular carcinoma
2) Refractory pleural effusion or ascites
3) Allergic reaction to iodine contrast material
4) Severe heart disease
5) Active infection excluding hepatitis B or C viral infection
6) Active concomitant malignancy
7) Severe mental disorder
8) Severe allergic reaction to drug
9) Severe complication
10) Pregnant and lactating females; females of childbearing age unless using effective contraception
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masafumi Ikeda, MD.
Organization National Cancer Center Hospital
Division name Hepatobiliary and Pancreatic Oncology Division
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL 03-3542-2511
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masafumi Ikeda, MD.
Organization FMP HAI Coordinating Office
Division name Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL 03-3542-2511
Homepage URL
Email

Sponsor
Institute Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2006 Year 09 Month 12 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2005 Year 09 Month 22 Day
Date of IRB
Anticipated trial start date
2005 Year 10 Month 01 Day
Last follow-up date
2009 Year 10 Month 01 Day
Date of closure to data entry
2009 Year 12 Month 01 Day
Date trial data considered complete
2009 Year 12 Month 01 Day
Date analysis concluded
2010 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 09 Month 12 Day
Last modified on
2010 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000591

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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