UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048984 |
|---|---|
| Receipt number | R000054265 |
| Scientific Title | Feasibility study of hyperthermic treatment by ASKIRF-8 for solid tumors |
| Date of disclosure of the study information | 2022/10/01 |
| Last modified on | 2023/09/29 12:27:28 |
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Basic information
Public title
Feasibility study of hyperthermic treatment by ASKIRF-8 for solid tumors
Acronym
Feasibility study of hyperthermic treatment
Scientific Title
Feasibility study of hyperthermic treatment by ASKIRF-8 for solid tumors
Scientific Title:Acronym
Feasibility study of hyperthermic treatment
Region
| Japan |
Condition
Condition
Solid tumors
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm feasibility of hyperthermic treatment as adjunct therapy with 6months hyperthermic treatment by ASKIRF-8 for solid tumors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Completion rate of scheduled hyperthermic treatment
Key secondary outcomes
Incidence and grade of adverse reactions.
6-month and 1-year overall survival
6-month and 1-year relapse free survival
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
| Device,equipment |
Interventions/Control_1
ASKIRF-8
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Solid tumor with histological proof.
2. Performance status (PS) 0 to 3
Key exclusion criteria
1. Ophthalmological cancer and brain tumors
2. Hematological malignancies
3. Metal in around the treatment region
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Tsurumi |
Organization
Matsunami General Hospital
Division name
Division of Hematology and Medical Oncology
Zip code
501-6062
Address
185-1 Dendai Kasamatsu-cho Hashima-gun, Gifu
TEL
058-388-0111
htsuru@gifu-u.ac.ip
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Hara |
Organization
Matsunami General Hospital
Division name
Division of Hematology and Medical Oncology
Zip code
501-6062
Address
185-1 Dendai Kasamatsu-cho Hashima-gun, Gifu
TEL
058-388-0111
Homepage URL
https://www.matsunami-hsp.or.jp/houjin/corporate/medical_ethics/
haratake@muh.biglobe.ne.jp
Sponsor or person
Institute
Matsunami General Hospital
Division of Hematology and Medical Oncology
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
Matsunami General Hospital
Address
Division of Hematology and Medical Oncology
Tel
058-388-0111
info@mghg.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 | 10 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 21 | Day |
Last modified on
| 2023 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054265
