UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007665
Receipt No. R000009033
Scientific Title Hepatic Arterial Infusion of deferoxamine for advanced hepatocellular carcinoma patients with impaired liver function: prospective randomized study
Date of disclosure of the study information 2012/04/09
Last modified on 2019/04/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Hepatic Arterial Infusion of deferoxamine for advanced hepatocellular carcinoma patients with impaired liver function: prospective randomized study
Acronym DFO for advanced HCC with impaired liver function
Scientific Title Hepatic Arterial Infusion of deferoxamine for advanced hepatocellular carcinoma patients with impaired liver function: prospective randomized study
Scientific Title:Acronym DFO for advanced HCC with impaired liver function
Region
Japan

Condition
Condition advanced hepatocellular carcinoma with impaired liver function
Classification by specialty
Hepato-biliary-pancreatic medicine Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We investiated the efficacy of hepatic arterial infusion using deferoxamine compared with UFT, in advanced hepatocellular carcinoma patients with impaired liver function who were non-responders for chemotherapy with anticancer drugs in prospective randomized study.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Survival
Key secondary outcomes Response, Progression-free survival, Safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 deferoxamine
Interventions/Control_2 UFT
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) Patients with advanced hepatocellular carcinoma
2) Non-responders for chemotherapy with anticancer drugs
3) Patients who have no influence on previous treatment
4) Performance status(PS) 0 or 1
5) Child-Pugh B
6) Favorable function of major organs (bone marrow, kidney, heart), and meeting citeria as follows:
(1) WBC >= 2500/mm3
(2) platelet count>= 50000/mm3
(3) hemogrobin level >= 9.0g/dl
(4) total bilirubin <= 3.0mg/dl
(5) serum creatinine level < 2mg/dl
(6) BUN <= 25mg/dl
(7) prothrombin time activity >= 50%
7) age >= 20years, male and female
Key exclusion criteria 1) Severe coexisting illness (expect for chronic hepatitis or liver cirrhosis)
2) Active bouble cancers
3) Past history of hypersensitivity for drugs including iodine and contrast agent
4) Patients with pregnancy, lactation or possibility of pregnancy
5) Past history of interstitial pneumonia
6) Chronic respiratory failure
7) Patients who judged as inadequacy due to other reasons by the doctor
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiro Yamasaki
Organization Yamaguchi University School of Medicine
Division name First Department of Internal Medicine
Zip code
Address 1-1-1 Minamikogushi, Ube, Yamaguchi
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Yamaguchi University School of Medicine
Division name First Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
Email t.yama@yamaguchi-u.ac.jp

Sponsor
Institute First Department of Internal Medicine, Yamaguchi University School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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 山口大学医学部附属病院(山口県)、国立国際医療研究センター国府台病院(千葉県)

Other administrative information
Date of disclosure of the study information
2012 Year 04 Month 09 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Terminated
Date of protocol fixation
2012 Year 03 Month 15 Day
Date of IRB
2012 Year 03 Month 28 Day
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 04 Month 04 Day
Last modified on
2019 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009033

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.