UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002488 |
|---|---|
| Receipt number | R000003029 |
| Scientific Title | A randomized controlled trial of stereotactic body radiation therapy (SBRT) with radiofrequency ablation (RFA) for small hepatocellular carcinoma |
| Date of disclosure of the study information | 2009/09/16 |
| Last modified on | 2015/03/14 16:00:26 |
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Basic information
Public title
A randomized controlled trial of stereotactic body radiation therapy (SBRT) with radiofrequency ablation (RFA) for small hepatocellular carcinoma
Acronym
A randomized controlled trial of SBRT with RFA for small hepatocellular carcinoma
Scientific Title
A randomized controlled trial of stereotactic body radiation therapy (SBRT) with radiofrequency ablation (RFA) for small hepatocellular carcinoma
Scientific Title:Acronym
A randomized controlled trial of SBRT with RFA for small 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
To compare the efficacy and safety of stereotactic body radiation therapy with those of radiofrequency ablation in the treatment of small hepatocellular carcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Three-year survival
Key secondary outcomes
Three-year local tumor control rate
Incidence of adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Stereotactic body radiation therapy
A total dose of 48 Gy is planned in 4 fractions over 4-8 days
Interventions/Control_2
Percutaneous radiofrequency ablation
One procedure per week, one or more procedures will be performed
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) Histopathologically confirmed carcinoma or a lesion showing characteristic features of hepatocellular carcinoma (HCC) on dynamic CT imaging
(2) Either a single lesion 5 cm or less in diameter, or two lesions each 3 cm or less in diameter
(3) Ineligibility for surgical resection or transplantation, or refusal to undergo surgical resection or transplantation
(4) No vascular invasion and no extrahepatic metastasis
(5) Liver function of Child-Pugh class A
(6) Platelet count more than 50000 per cubic millimeter
(7) Prothrombin time ratio (ie, normal time divided by patient's time) greater than 50%
(8) ECOG performance status (PS) of 0 or 1
Key exclusion criteria
(1) Active infectious disease requiring treatment
(2) In pregnancy or lactation, or with expectation of pregnancy
(3) History of irradiation to body trunk for any disease
(4) Implantation of a permanent pacemaker
(5) Tumors abutting the stomach or intestinal loop
(6) Simultaneous malignancies
Target sample size
288
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinji Katsushima |
Organization
National Hospital Organization
Kyoto Medical Center
Division name
Department of Gastroenterology
Zip code
Address
1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, JAPAN
TEL
075-641-9161
skatsush@kyotolan.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinji Katsushima |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Department of Gastroenterology
Zip code
Address
1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, JAPAN
TEL
075-641-9161
Homepage URL
skatsush@kyotolan.hosp.go.jp
Sponsor or person
Institute
Department of Gastroenterology,
National Hospital Organization,
Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
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
独立行政法人国立病院機構京都医療センター（京都府）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 09 | Month | 16 | 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
| 2009 | Year | 08 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 14 | Day |
Last modified on
| 2015 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003029
