UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047923 |
|---|---|
| Receipt number | R000054633 |
| Scientific Title | A multicenter retrospective study comparing the safety and efficacy of carbon ion radiotherapy and radiofrequency ablation in early stage hepatocellular carcinoma |
| Date of disclosure of the study information | 2022/06/03 |
| Last modified on | 2022/06/02 09:11:06 |
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Basic information
Public title
A multicenter retrospective study comparing the safety and efficacy of carbon ion radiotherapy and radiofrequency ablation in early stage hepatocellular carcinoma
Acronym
A multicenter retrospective study comparing the safety and efficacy of carbon ion radiotherapy and radiofrequency ablation in early stage hepatocellular carcinoma
Scientific Title
A multicenter retrospective study comparing the safety and efficacy of carbon ion radiotherapy and radiofrequency ablation in early stage hepatocellular carcinoma
Scientific Title:Acronym
A multicenter retrospective study comparing the safety and efficacy of carbon ion radiotherapy and radiofrequency ablation in early stage hepatocellular carcinoma
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the safety and efficacy of carbon ion radiotherapy and radiofrequency ablation in patients with hepatocellular carcinoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Progression free survival
Local control
Complications
ALBI score after six months of treatment
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with first hepatocellular carcinoma between April 2003 and March 2018 and treated with carbon ion radiotherapy or radiofrequency ablation.
Hepatocellular carcinoma within 5 cm for a single tumor or within 3 cm for 2 or 3 tumors.
Key exclusion criteria
Patients with evidence of vascular invasion or distant metastasis.
Patients with advanced carcinoma at the time of initial diagnosis of hepatocellular carcinoma.
Patients with Child-Pugh C at the time of diagnosis of initial hepatocellular carcinoma.
Patients who refuse to participate in this study.
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Kato |
Organization
Chiba university
Division name
Department of Gastroenterology
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
043-222-7171
kato.naoya@chiba-u.jp
Public contact
Name of contact person
| 1st name | Naoto |
| Middle name | |
| Last name | Fujita |
Organization
Chiba university
Division name
Department of Gastroenterology
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
043-222-7171
Homepage URL
n.fujita53@gmail.com
Sponsor or person
Institute
Chiba university
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of the Graduate School of Medicine, Chiba University
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677, JAPAN
Tel
043-222-7171
inohana-rinri@chiba-u.jp
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
| 2022 | Year | 06 | Month | 03 | 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
631
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
| 2018 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The objective is to compare the safety and efficacy of carbon ion radiotherapy and radiofrequency ablation in patients with hepatocellular carcinoma.
Management information
Registered date
| 2022 | Year | 06 | Month | 02 | Day |
Last modified on
| 2022 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054633
