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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029314
Receipt No. 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

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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
Email 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
Email kazuhiko.hayashi@qst.go.jp

Sponsor
Institute National Institutes for Quantum and Radiological Sciences and Technology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033513

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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