UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and Efficacy of Short-Term Steroid in Patients with Hepatocellular Carcinoma undergoing Transarterial Chemo Embolization - A Randomized, Double-Blind, Placebo Controlled Trial
Title of the study (Brief title)	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	Osamu Yokosuka
Organization	Chiba University Hospital
Division name	Department of Gastroenterology
Address	1-8-1 Inohana, Chuou-ku, Chiba
TEL
Email

Public contact
Name of contact person	Sadahisa Ogasawara
Organization	Chiba University Hospital
Division name	Department of Gastroenterology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 09 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000005144