UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055912 |
|---|---|
| Receipt number | R000063886 |
| Scientific Title | Carbon-ion radiotherapy for submandibular and sublingual gland carcinomas |
| Date of disclosure of the study information | 2024/10/22 |
| Last modified on | 2024/10/22 11:53:47 |
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Basic information
Public title
Carbon-ion radiotherapy for submandibular and sublingual gland carcinomas
Acronym
Carbon-ion radiotherapy for submandibular and sublingual gland carcinomas
Scientific Title
Carbon-ion radiotherapy for submandibular and sublingual gland carcinomas
Scientific Title:Acronym
Carbon-ion radiotherapy for submandibular and sublingual gland carcinomas
Region
| Japan |
Condition
Condition
submandibular and sublingual gland carcinomas
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will analyze the treatment outcomes of patients with submandibular gland cancer and sublingual gland cancer who underwent carbon-ion radiotherapy at our hospital, and examine its safety and efficacy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Local control, Over all survival, advers events
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
| Other |
Interventions/Control_1
Carbon-ion radiaotherapy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with submandibular and sublingual gland cancer who underwent carbon-ion radiation therapy between April 1997 and July 2024.
Key exclusion criteria
Patients who have requested that their data not be used for the purpose of disclosing information about this study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Ikawa |
Organization
National Institutes for Quantum Science and Technology (QST)
Division name
QST Hospital
Zip code
263
Address
4-9-1, Anagawa, Inage, Chiba city, Chiba, Japan
TEL
0432063306
ikawa.hiroaki@qst.go.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Ikawa |
Organization
National Institutes for Quantum Science and Technology (QST)
Division name
QST Hospital
Zip code
263-8555
Address
4-9-1, Anagawa, Inage, Chiba city, Chiba, Japan
TEL
0432063306
Homepage URL
ikawa.hiroaki@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Science and Technology (QST)
Institute
Department
Personal name
Funding Source
Organization
National Institutes for Quantum Science and Technology (QST)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institutes for Quantum Science and Technology (QST)
Address
4-9-1, Anagawa, Inage, Chiba city, Chiba, Japan
Tel
0432063306
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
| 2024 | Year | 10 | Month | 22 | 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
40
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
No longer recruiting
Date of protocol fixation
| 1997 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 1997 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2024 | Year | 10 | Month | 22 | Day |
Last modified on
| 2024 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063886
