UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004317 |
|---|---|
| Receipt number | 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 07:46:04 |
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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
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
ogasawaras@graduate.chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005144
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
