UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000487 |
|---|---|
| Receipt number | 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 00:40:32 |
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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
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
Sponsor or person
Institute
Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000591
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