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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029522
Receipt No. R000033734
Official scientific title of the study Carbon ion radiotherapy for oral malignancies
Date of disclosure of the study information 2017/10/12
Last modified on 2017/10/12

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Basic information
Official scientific title of the study Carbon ion radiotherapy for oral malignancies
Title of the study (Brief title) C-ion RT for Oral malignancies
Region
Japan

Condition
Condition Oral malignancies
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to evaluate the efficacy and safety of carbon-ion radiotherapy (C-ion RT) for oral malignancies
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Local control, progression free survival rates, and overall survival
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 radiotherapy for oral malignancies
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients treated with C-ion RT alone for oral malignancies.
All tumors were pathologically confirmed malignant tumor.
The patients had medically inoperable tumors or declined surgery.
Key exclusion criteria with active other carcinoma
Target sample size 83

Research contact person
Name of lead principal investigator Hiroaki Ikawa
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
Email ikawa.hiroaki@qst.go.jp

Public contact
Name of contact person Hiroaki Ikawa
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 ikawa.hiroaki@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 Other
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
2017 Year 10 Month 12 Day

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 10 Month 12 Day
Anticipated trial start date
2017 Year 10 Month 13 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

Management information
Registered date
2017 Year 10 Month 12 Day
Last modified on
2017 Year 10 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033734

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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