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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004317
Receipt No. R000005144
Scientific Title Safety and Efficacy of Short-Term Steroid in Patients with Hepatocellular Carcinoma undergoing Transarterial Chemo Embolization - A Randomized, Double-Blind, Placebo Controlled Trial
Date of disclosure of the study information 2010/10/05
Last modified on 2018/02/13

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Basic information
Public title Safety and Efficacy of Short-Term Steroid in Patients with Hepatocellular Carcinoma undergoing Transarterial Chemo Embolization - A Randomized, Double-Blind, Placebo Controlled Trial
Acronym Safety and Efficacy of Short-Term Steroid in Patients with Hepatocellular Carcinoma undergoing Transarterial Chemo Embolization
Scientific Title Safety and Efficacy of Short-Term Steroid in Patients with Hepatocellular Carcinoma undergoing Transarterial Chemo Embolization - A Randomized, Double-Blind, Placebo Controlled Trial
Scientific Title:Acronym Safety and Efficacy of Short-Term Steroid in Patients with Hepatocellular Carcinoma undergoing Transarterial Chemo Embolization
Region
Japan

Condition
Condition Hepatocellular Carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of safety and efficacy of Short-Term Steroid in Patients with Hepatocellular Carcinoma undergoing Transarterial Chemo-Embolization
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The proportion of patients with complete response, defined as no fever, no nausea, no vomiting, and no anorexia, during 120 hours after TACE.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 short term steroid administration
Interventions/Control_2 Placebo
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 who have been diagnosed with hepatocellular carcinoma by histologycally or typical diagnostic images
2)No indication for surgical resection, local thrapy(Percutaneous ethanol injection, radiofrequency ablation, microwave coagulation therapy)
3)Performance status (ECOG scale): 0,1
4)Child-Pugh A and B
5)Adequate bone marrow, liver, renal and cardiac function as assessed by the following
a)Hemoglobin >= 8.5 g/dl
b)Neutrophil >= 1000/mm3
c)Total bilirubin < 3.0mg/dl
d)Liver transaminases <= 10 x Upper limit of Normal(ULN)
e)PT(INR) <= 2.3
f)ALB >= 2.5 g/dl
g)Cre <= 1.5 x ULN
Key exclusion criteria 1)Second primary malignancy
2)Active infection
3)Extrahepatic metastasis
4)Epatoencepharopathy
5)Uncontrolable Pleural effusion and ascitis
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Osamu Yokosuka
Organization Chiba University Hospital
Division name Department of Gastroenterology
Zip code
Address 1-8-1 Inohana, Chuou-ku, Chiba
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Sadahisa Ogasawara
Organization Chiba University Hospital
Division name Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
Email ogasawaras@graduate.chiba-u.jp

Sponsor
Institute Chiba University Hospital
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

Other administrative information
Date of disclosure of the study information
2010 Year 10 Month 05 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 Completed
Date of protocol fixation
2010 Year 09 Month 21 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 10 Month 04 Day
Last modified on
2018 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005144

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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