UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020741 |
|---|---|
| Receipt number | R000023937 |
| Scientific Title | The effectiveness of oncothermia for the advanced cancer (solid tumor) |
| Date of disclosure of the study information | 2016/01/26 |
| Last modified on | 2021/03/22 10:43:07 |
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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 | Obstetrics 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
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
kanamori@med.u-toyama.ac.jp
Sponsor or person
Institute
Human Science 1, University of Toyama
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023937
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
