UMIN-CTR Clinical Trial

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
Email	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/
Email	nsurgery@med.u-toyama.ac.jp

Sponsor
Institute	Toyama University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025903