UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022478 |
|---|---|
| Receipt number | R000025903 |
| Scientific Title | Toyama Oncothermia Study for Intractable Malignant Brain Tumor |
| Date of disclosure of the study information | 2016/05/26 |
| Last modified on | 2021/06/03 10:37:12 |
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Basic information
Public title
Toyama Oncothermia Study for Intractable Malignant
Brain Tumor
Acronym
Toyama Oncothermia Study for Intractable Malignant
Brain Tumor
Scientific Title
Toyama Oncothermia Study for Intractable Malignant
Brain Tumor
Scientific Title:Acronym
Toyama Oncothermia Study for Intractable Malignant
Brain Tumor
Region
| Japan |
Condition
Condition
Malignant brain tumor
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study is aimed to assess the safety and feasibility of a novel adjuvant therapy "Oncothermia" for intractable malignant brain tumor.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
1) Outcome
Clinical outcome is assessed using RECIST (Response Evaluation Criteria in Solid Tumors) on MRI and is categorized into complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD).
2) Incidence of the following adverse events
a) General condition
Fatigue, fever, headache, hypotension, bradycardia, respiratory distress, allergic reaction
b) Local condition
Local pain, dermatitis, skin necrosis
c) Laboratory examinations
RBC, Hb, WBC, platelet, ALT (GOT), AST (GPT), LDH, T-bil, Cr
d) Others
Key secondary outcomes
1) Karnofsky performance status (KPS)
2) Pre- and post-treatment radiological findings
a) MRI
b) MRS
c) 201Tl SPECT
d) 16F-FDG PET
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Oncothermia
80-W therapy for 60 min/day
Twice/week
8 therapies/course
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
1) 20 years old or older
2) Histologically diagnosed as malignant brain tumor
3) Intractable patients who do not respond to standardized therapy or high-risk patients who cannot undergo standardized therapy
4) Expected survival longer than 2 months
5) Informed consent obtained from the patients themselves
Key exclusion criteria
1) Infected patients
2) Malnutrition
3) Severe comorbid such as heart disorders, colon dysfunction, lung fibrosis, uncontrolled diabetes mellitus, and chronic renal failure
4) Psychological disorders
5) Pregnancy
6) Others
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Kuroda |
Organization
Toyama University Hospital
Division name
Neurosurgery
Zip code
930-0194
Address
2630 Sugitani, Toyama, Japan
TEL
076-434-7348
skuroda@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiko |
| Middle name | |
| Last name | Takado |
Organization
Toyama University Hospital
Division name
Neurosurgery
Zip code
930-0194
Address
2630 Sugitani, Toyama, Japan
TEL
076-434-7348
Homepage URL
http://www.med.u-toyama.ac.jp/nsurgery/
nsurgery@med.u-toyama.ac.jp
Sponsor or person
Institute
Toyama University Hospital
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
IRB
Address
2630 Sugitani, Toyama, Japan
Tel
076-434-7348
nsurgery@med.u-toyama.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
| 2016 | Year | 05 | Month | 26 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
20
Results
Not yet
Results date posted
| 2021 | Year | 06 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Unpublished
Participant flow
Unpublished
Adverse events
Unpublished
Outcome measures
Unpublished
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 07 | 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
| 2016 | Year | 05 | Month | 26 | Day |
Last modified on
| 2021 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025903
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| Registered date | File name |
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