UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029314 |
|---|---|
| Receipt number | R000033513 |
| Scientific Title | Carbon-ion radiotherapy for the lacrimal gland carcinomas extending to extra-orbital tissues |
| Date of disclosure of the study information | 2017/10/09 |
| Last modified on | 2018/02/02 13:25:06 |
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Basic information
Public title
Carbon-ion radiotherapy for the lacrimal gland carcinomas extending to extra-orbital tissues
Acronym
Carbon-ion radiotherapy for the lacrimal gland carcinomas
Scientific Title
Carbon-ion radiotherapy for the lacrimal gland carcinomas extending to extra-orbital tissues
Scientific Title:Acronym
Carbon-ion radiotherapy for the lacrimal gland carcinomas
Region
| Japan |
Condition
Condition
the lacrimal gland carcinoma
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of carbon-ion radiotherapy (C-ion RT) for the lacrimal gland carcinomas (LGCs) extending to extra-orbital tissues
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Local control rate
Key secondary outcomes
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
| 0 | years-old | <= |
Age-upper limit
| 999 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) a histologically proven carcinoma of the lacrimal gland extending to extra-orbital tissues
2) measurable carcinoma
3) performance status 0-2
4) no systemic therapy, such as chemotherapy, within 1 month of commencing re-irradiation with CIRT
5) N0M0 or N1M0
Key exclusion criteria
co-existent malignant active tumor
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hayashi Kazuhiko |
Organization
National Institutes for Quantum and Radiological Sciences and Technology
Division name
Hospital of the National Institute of Radiological Sciences
Zip code
Address
Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
TEL
043-206-3360
kazuhiko.hayashi@qst.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hayashi Kazuhiko |
Organization
National Institutes for Quantum and Radiological Sciences and Technology
Division name
Hospital of the National Institute of Radiological Sciences
Zip code
Address
Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
TEL
043-206-3360
Homepage URL
kazuhiko.hayashi@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum and Radiological Sciences and Technology
Institute
Department
Personal name
Funding Source
Organization
Hospital of the National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Sciences and Technology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2017 | Year | 09 | Month | 27 | Day |
Last modified on
| 2018 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033513
