UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036455 |
|---|---|
| Receipt number | R000041544 |
| Scientific Title | Evaluation of the clinical outcome and cost effectiveness of carbon ion radiotherapy or transarterial chemoembolization to localized hepatocellular carcinoma |
| Date of disclosure of the study information | 2019/04/10 |
| Last modified on | 2019/04/09 17:17:48 |
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Basic information
Public title
Evaluation of the clinical outcome and cost effectiveness of carbon ion radiotherapy or transarterial chemoembolization to localized hepatocellular carcinoma
Acronym
Evaluation of the clinical outcome and cost effectiveness of carbon ion radiotherapy or transarterial chemoembolization to localized hepatocellular carcinoma
Scientific Title
Evaluation of the clinical outcome and cost effectiveness of carbon ion radiotherapy or transarterial chemoembolization to localized hepatocellular carcinoma
Scientific Title:Acronym
Evaluation of the clinical outcome and cost effectiveness of carbon ion radiotherapy or transarterial chemoembolization to localized 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 evaluate the clinical outcomes and cost effectiveness of carbon ion radiotherapy or transarterial chemoembolization to localized hepatocellular carcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival rate
Local control rate
Cost effectiveness
Key secondary outcomes
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with localized HCC treated with C-ion RT or TACE.
Key exclusion criteria
The patient with: 1) direct infiltration of the gastrointestinal tract; 2) intrahepatic metastasis; 3) distant metastasis, and; 4) major vascular invasion were excluded.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Shibuya |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Radiation Oncology
Zip code
371-8511
Address
3-39-22, Syowa-machi, Maebashi, Gunma
TEL
027-220-8383
shibukei@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Shiba |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Radiation Oncology
Zip code
371-8511
Address
3-39-22, Syowa-machi, Maebashi, Gunma
TEL
027-220-8383
Homepage URL
shiba4885@yahoo.co.jp
Sponsor or person
Institute
Department of Radiation Oncology, Gunma University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Radiation Oncology, Gunma University Graduate School of Medicine
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
Gunma University Hospital Institutional Review Board
Address
3-39-15, Syowa-machi, Maebashi, Gunma
Tel
027-220-8740
gunma-ciru@ml.gunma-u.ac.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
| 2019 | Year | 04 | Month | 10 | 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
54
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective analysis
Management information
Registered date
| 2019 | Year | 04 | Month | 09 | Day |
Last modified on
| 2019 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041544
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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