UMIN-CTR Clinical Trial

Basic information
Public title	The effectiveness of oncothermia for the advanced cancer (solid tumor)
Acronym	Oncothermia research
Scientific Title	The effectiveness of oncothermia for the advanced cancer (solid tumor)
Scientific Title:Acronym	Oncothermia research
Region	Japan

Condition
Condition	Advanced Cancer (Solid Tumor)
Classification by specialty	Pneumology Gastrointestinal surgery Hepato-biliary-pancreatic surgery Breast surgery Obsterics and gynecology Dermatology Orthopedics Radiology Neurosurgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The evaluation of the safty and effectiveness of the oncothermia for the advanced cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Responce evaluation citeria in solid tumor (RECIST) within 1 month after intervention
Key secondary outcomes	Performane status (ECOG) within 1 month after intervention

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	Device,equipment
Interventions/Control_1	Oncothermia (1hr/1 time), 2 times a week. Highest energy is 140 W.
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	10 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Malignant tumor with histopathological diagnosis 2)Non-responders by standard treatment 3)Informed consent is taken
Key exclusion criteria	1)with obvious infection 2)with severe low-level of nutrition 3)with other severe complication 4)with severe psychological disorder 5)pregnant woman/ with a baby 6)inadequate case by the doctor
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masahiko Kanamori
Organization	University of Toyama
Division name	Human Science 1
Zip code
Address	2630 Sugitani, Toyama
TEL	076-434-7405
Email	kanamori@med.u-toyama.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Masahiko Kanamori
Organization	University of Toyama
Division name	Human Science 1
Zip code
Address	2630 Sugitani, Toyama
TEL	076-434-7405
Homepage URL
Email	kanamori@med.u-toyama.ac.jp

Sponsor
Institute	Human Science 1, University of Toyama
Institute
Department

Funding Source
Organization	University of Toyama
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	富山大学附属病院（富山県）

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 26 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	Terminated
Date of protocol fixation	2015 Year 01 Month 12 Day
Date of IRB	2014 Year 05 Month 15 Day
Anticipated trial start date	2015 Year 02 Month 01 Day
Last follow-up date	2019 Year 01 Month 11 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2020 Year 05 Month 31 Day
Date analysis concluded	2020 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date	2016 Year 01 Month 26 Day
Last modified on	2021 Year 03 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023937