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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022828
Receipt No. R000026306
Official scientific title of the study Long-term outcomes after carbon ion radiotherapy for oral mucosal malignant melanoma
Date of disclosure of the study information 2016/07/01
Last modified on 2016/06/21

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Basic information
Official scientific title of the study Long-term outcomes after carbon ion radiotherapy for oral mucosal malignant melanoma
Title of the study (Brief title) Long-term outcomes after carbon ion radiotherapy for oral mucosal malignant melanoma
Region
Japan

Condition
Condition Mucosal malignant melanoma
Classification by specialty
Radiology Dental medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study is to evaluate the long-term efficacy of carbon-ion radiotherapy (C-ion RT) for Oral mucosal malignant melanoma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 5-year overall survival rate
Key secondary outcomes 5-year local control rate, Toxicities (acute and late)

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients treated with C-ion RT alone.
All tumors were pathologically confirmed.
The patients had medically inoperable tumors or declined surgery.
Key exclusion criteria All patients received C-ion RT as the primary treatment.
Target sample size 20

Research contact person
Name of lead principal investigator Koto Masashi
Organization National Institute of Radiological Science Hospital, National Institutes for Quantum and Radiological Sciences and Technology
Division name National Institute of Radiological Science Hospital
Address Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
TEL 043-206-3360
Email koto.masashi@qst.go.jp

Public contact
Name of contact person Koto Masashi
Organization National Institutes for Quantum and Radiological Sciences and Technology
Division name National Institute of Radiological Science Hospital
Address Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
TEL 043-206-3360
Homepage URL
Email koto.masashi@qst.go.jp

Sponsor
Institute The Research Project with Heavy Ions at the National Institute of radiological Sciences (NIRS)-Heavy Ion Medical Accelerator in Chiba (HIMAC).
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2016 Year 07 Month 01 Day

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 06 Month 21 Day
Anticipated trial start date
2016 Year 06 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information Retrospective study

Management information
Registered date
2016 Year 06 Month 21 Day
Last modified on
2016 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026306

Research Plan
Registered date Registrant File name

Research case data specifications
Registered date Registrant File name

Research case data
Registered date Registrant File name


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