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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024473
Receipt No. R000028156
Official scientific title of the study A retrospective multicenter study of carbon ion radiotherapy for the head and neck cancer except sarcoma: Japan Carbon Ion Radiotherapy Study Group Study (1402 HN)
Date of disclosure of the study information 2016/10/19
Last modified on 2016/10/18

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Basic information
Official scientific title of the study A retrospective multicenter study of carbon ion radiotherapy for the head and neck cancer except sarcoma: Japan Carbon Ion Radiotherapy Study Group Study (1402 HN)
Title of the study (Brief title) J-CROS 1402 HN
Region
Japan

Condition
Condition Head and neck cancer except sarcoma
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of carbon ion radiotherapy for patients with head and neck cancer except sarcoma treated with carbon ion radiotherapy in Japan.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Overall survival rate
Local control rate
Adverse event
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) histologically confirmed malignancy (except choroidal melanoma), no bone or soft tissue tumors, 2) N0 or N1 M0 status, 3) medically inoperable tumors or surgery refusal, 4) definitive intent, 5) measurable tumors, and 6) an Eastern Cooperative Oncology Group performance status of 0-2.
Key exclusion criteria Patients who previously underwent irradiation for the same lesion were excluded.
Target sample size 1000

Research contact person
Name of lead principal investigator Tadashi Kamada
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
TEL 043-206-3360
Email kamada.tadashi@qst.go.jp

Public contact
Name of contact person Masashi Koto
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
TEL 043-206-3360
Homepage URL
Email koto.masashi@qst.go.jp

Sponsor
Institute National Institutes for Quantum and Radiological Sciences and Technology
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
2016 Year 10 Month 19 Day

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 03 Month 31 Day
Anticipated trial start date
2015 Year 04 Month 27 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 None

Management information
Registered date
2016 Year 10 Month 18 Day
Last modified on
2016 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028156

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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