UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008502 |
|---|---|
| Receipt number | R000009993 |
| Scientific Title | Stereotactic body radiation therapy for hepatocellular carcinoma. |
| Date of disclosure of the study information | 2012/07/23 |
| Last modified on | 2017/10/02 10:00:33 |
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Basic information
Public title
Stereotactic body radiation therapy for hepatocellular carcinoma.
Acronym
Stereotactic body radiation therapy for hepatocellular carcinoma.
Scientific Title
Stereotactic body radiation therapy for hepatocellular carcinoma.
Scientific Title:Acronym
Stereotactic body radiation therapy for hepatocellular carcinoma.
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma.
Classification by specialty
| Hepato-biliary-pancreatic medicine | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We perform stereotactic body radiotherapy as additional treatment after the TACE for a local hepatocellular carcinoma (greatest dimension 5cm or less). Further we examine the effectiveness and safety and follow up them after this treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Local tumor control rate, safety
Key secondary outcomes
overall survival rate, disease free survival rate
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) hypervascular HCC nodules, each up to 50 mm in diameter; (2) not suitable for the hepatic resection or ablative therapy; (3) Child-Turcotte-Pugh (CTP) score<7.
Key exclusion criteria
neighboring the Intestinal tract
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuaki Chayama |
Organization
Hiroshima university
Division name
Department of Medicine and Molecular Science
Zip code
Address
1-2-3 Kasumi, Minamiku, Hiroshima
TEL
082-257-5555
chayama@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Aikata |
Organization
Hiroshima university
Division name
Department of Medicine and Molecular Science
Zip code
Address
1-2-3 Kasumi, Minamiku, Hiroshima
TEL
082-257-5555
Homepage URL
aikata@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima university hospital
Institute
Department
Personal name
Funding Source
Organization
Hiroshima university hospital
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
広島大学病院（広島）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 23 | 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 | 16 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
We perform stereotactic body radiotherapy as additional treatment after the TACE for a local hepatocellular carcinoma (greatest dimension 5cm or less). Further we examine the effectiveness and safety and follow up them after this treatment.
Management information
Registered date
| 2012 | Year | 07 | Month | 23 | Day |
Last modified on
| 2017 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009993
| 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 |
