UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026925 |
|---|---|
| Receipt number | R000030884 |
| Scientific Title | Combination therapy of immuno checkpoint inhibitors and radiosensitization treatment for metastatic melanoma |
| Date of disclosure of the study information | 2017/04/10 |
| Last modified on | 2023/10/16 17:19:55 |
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Basic information
Public title
Combination therapy of immuno checkpoint inhibitors and radiosensitization treatment for metastatic melanoma
Acronym
Immuno-radiosensitization treatment for metastatic melanoma
Scientific Title
Combination therapy of immuno checkpoint inhibitors and radiosensitization treatment for metastatic melanoma
Scientific Title:Acronym
Immuno-radiosensitization treatment for metastatic melanoma
Region
| Japan |
Condition
Condition
metastatic melanoma
Classification by specialty
| Dermatology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We evaluate whether metastic lesions decrease in size or disappear by simultaneous therapy of KORTUC and immuno checkpoint therapy for metastasic melanoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The effect of tumor reduction is evaluated by diagnostic imaging at one month, two months and three months after end of treatment. Thereafter, every three months until two years later after treatment termination , and after that, once in six months.
Key secondary outcomes
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
| Medicine | Device,equipment |
Interventions/Control_1
After intratumor injection of hydrogen peroxide 0.5ml and sodium hyaluronate 2.5ml mixture once or twice per week, radiotherapy is give to tumor during four to six weeks.
Simultaneously, intravenous drip of nivolumab (3mg/kg) everty two weeks or pembrolizumab (2mg/kg) everty two weeks or ipilimumab (3mg/kg) everty three weeks is performed. Treatment of nivolumab or pembrolizumab is continued until tumor disappearance. However, ipilimumab is administrated four times in total.
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
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Inoperable metastatic melanoma
2) Be able to lie quietly for more than thirty minutes
3) SpO2 not less than 90%
4) Body temperature no more than 37.5 degrees
5) Gaining informed consent from patients or legal representatives
Key exclusion criteria
1) Unable to secure infusion route of drugs by using ultrasound or CT
2) Determined to have high risk for bleeding by principalinvestigator or sub-investigators
3) Determined to have high risk for infection by principalinvestigator or sub-investigators
4) Determined to be inappropriate for this trial.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Shigetoshi |
| Middle name | |
| Last name | Sano |
Organization
Kochi University, Kochi Medical School
Division name
dermatology
Zip code
783-8505
Address
Kohasu, Okohcho, Nankoku, Kochi
TEL
0888802363
nakajima@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Shigetoshi |
| Middle name | |
| Last name | Sano |
Organization
Kochi University, Kochi Medical School
Division name
dermatology
Zip code
783-8505
Address
Kohasu, Okohcho, Nankoku, Kochi
TEL
0888802363
Homepage URL
nakajima@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University, Kochi Medical School
Institute
Department
Personal name
Funding Source
Organization
Kochi University, Kochi Medical School
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
Department of Data management in Next generation medical innovation of Kochi Medical School Hospital
Address
Kohasu,Okohcho, Nankoku, Kochi
Tel
0888665811
im62@kochi-u.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
| 2017 | Year | 04 | Month | 10 | 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
| 2017 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 10 | Day |
Last modified on
| 2023 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030884
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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