UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002172 |
|---|---|
| Receipt number | R000002667 |
| Scientific Title | Ion beam therapy with concurrent hepatic arterial infusion chemotherapy for advanced HCC, PhaseI/II study |
| Date of disclosure of the study information | 2009/07/14 |
| Last modified on | 2012/08/28 16:21:03 |
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Basic information
Public title
Ion beam therapy with concurrent hepatic arterial infusion chemotherapy for advanced HCC, PhaseI/II study
Acronym
Ion beam therapy with concurrent hepatic arterial infusion chemotherapy for advanced HCC
Scientific Title
Ion beam therapy with concurrent hepatic arterial infusion chemotherapy for advanced HCC, PhaseI/II study
Scientific Title:Acronym
Ion beam therapy with concurrent hepatic arterial infusion chemotherapy for advanced HCC
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of safety and therapeutic effect of ion beam theraphy with concurrent arterial infusion chemotherapy for advanced HCC
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
side effect, survival time and QOL
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Hepatic arterial infusion chemotherapy
Ion beam therapy(proton therapy, carbon-ion therapy)
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Unresectable HCC with tumor thronbosis and multiple intrahepatic metastases
Key exclusion criteria
Distal metastases
Acsites
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masao Murakami |
Organization
Hyogo Ion Beam Medical Center
Division name
Department of Radiology
Zip code
Address
1-2-1 Kouto, Shingu-cho, Tatsuno, Hyogo
TEL
0791-58-0100
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuki Terashima |
Organization
Hyogo Ion Beam Medical Center
Division name
Department of Radiology
Zip code
Address
1-2-1 Kouto, Shingu-cho, Tatsuno, Hyogo
TEL
0791-58-0100
Homepage URL
terashima@kmyr.jp
Sponsor or person
Institute
Department of Radiology, Hyogo Ion Beam Medical Center
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
| 2009 | Year | 07 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Date of protocol fixation
| 2009 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | 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 | 07 | Month | 08 | Day |
Last modified on
| 2012 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002667
