UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045603 |
|---|---|
| Receipt number | R000052059 |
| Scientific Title | Optimal irradiation field setting and prescribed dose in carbon-ion radiotherapy for sinonasal mucosal melanoma |
| Date of disclosure of the study information | 2021/09/30 |
| Last modified on | 2022/09/30 09:20:52 |
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Basic information
Public title
Optimal irradiation field setting and prescribed dose in carbon-ion radiotherapy for sinonasal mucosal melanoma
Acronym
carbon-ion radiotherapy for sinonasal mucosal melanoma
Scientific Title
Optimal irradiation field setting and prescribed dose in carbon-ion radiotherapy for sinonasal mucosal melanoma
Scientific Title:Acronym
carbon-ion radiotherapy for sinonasal mucosal melanoma
Region
| Japan |
Condition
Condition
Sinonasal mucosal melanoma
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the optimal irradiation field setting and prescribed dose in carbon-ion radiotherapy for sinonasal mucosal melanoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between local recurrence site, irradiation field, and prescribed dose.
Key secondary outcomes
Local control rate, overall survival rate, progression-free survival rate, late adverse event occurrence rate.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 15 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Sinonasal Mucosal melanoma patients who were prospectively enrolled in in-hospital treatment protocols 0007 and 0007 (2) from July 2001 to February 2018 and were treated with carbon-ion radiotherapy combined with DAV chemotherapy, which is a protocol treatment.
Key exclusion criteria
Refusal of use of clinical data for this study by the study subject or his / her agent.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Koto |
Organization
National Institutes for Quantum Sciences and Technology
Division name
QST Hospital
Zip code
263-8555
Address
4-9-1 Anagawa Inage Chiba
TEL
043-206-3306
koto.masashi@qst.go.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Koto |
Organization
National Institutes for Quantum Sciences and Technology
Division name
QST Hospital
Zip code
263-8555
Address
4-9-1 Anagawa Inage Chiba
TEL
043-206-3306
Homepage URL
koto.masashi@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Sciences and Technology
Institute
Department
Personal name
Funding Source
Organization
National Institutes for Quantum Sciences and Technology
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
National Institutes for Quantum Sciences and Technology
Address
4-9-1 Anagawa Inage Chiba
Tel
043-206-4706
helsinki@qst.go.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
| 2021 | Year | 09 | Month | 30 | 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
135
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
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 09 | Month | 29 | Day |
Last modified on
| 2022 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052059
