UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002863 |
|---|---|
| Receipt number | R000003485 |
| Scientific Title | A clinical trial of proton radiotherapy with local immunotherapy for recurrent cases with hepatocellular carcinoma |
| Date of disclosure of the study information | 2016/12/31 |
| Last modified on | 2011/07/21 11:34:35 |
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Basic information
Public title
A clinical trial of proton radiotherapy with local immunotherapy for recurrent cases with hepatocellular carcinoma
Acronym
Proton radiotherapy and immunotherapy for hepatic cancer
Scientific Title
A clinical trial of proton radiotherapy with local immunotherapy for recurrent cases with hepatocellular carcinoma
Scientific Title:Acronym
Proton radiotherapy and immunotherapy for hepatic cancer
Region
| Japan |
Condition
Condition
Hepatocellular Carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the safety of a treatment consisting of proton radiotherapy and local immunotherapy for recurrent cases with hepatocellular carcinoma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety
Prevention of recurrence
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Vaccine | Device,equipment |
Interventions/Control_1
Proton radiotherapy
Tumor immunotherapy by a novel adjuvant
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
Recurrent cases with locally advanced hepatocellular carcinoma
Life expectency is 6 months or more.
Proton radiotherapy is indicated.
KPS is 60% or more.
Hepatic function is preserved.
Key exclusion criteria
Initially diagnosed case
History of having other malignancies
Having autoimmune disorders
HIV positive
Uncontrollable complications such as infections, heart disorders or psychiatric disorders
Administration of anticancer drugs or corticosteroids within 4 months
Pregnant
Tuberculosis, or hyperreaction in DTH test with the advant
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Tsuboi |
Organization
University of Tsukuba
Division name
Proton medical research center, Graduate School of Comprehensive Human Sciences
Zip code
Address
1-1-1, Tennodai, Tsukuba, Ibaraki 305-8575, Japan
TEL
029-853-7100
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
University of Tsukuba
Division name
Proton Medical Research Center
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Proton Medical Research Center, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Ibaraki Prefecture
Organization
Division
Category of Funding Organization
Local Government
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
| 2016 | Year | 12 | Month | 31 | 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 | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | 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 | 12 | Month | 09 | Day |
Last modified on
| 2011 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003485
| 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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