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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024598
Receipt No. R000028299
Official scientific title of the study Prognostic factors of adenoid cystic carcinoma after carbon ion radiotherapy for the head and neck: the impact of histological subtypes.
Date of disclosure of the study information 2016/11/01
Last modified on 2016/10/27

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Basic information
Official scientific title of the study Prognostic factors of adenoid cystic carcinoma after carbon ion radiotherapy for the head and neck: the impact of histological subtypes.
Title of the study (Brief title) Prognostic factors of ACC after C-ion RT.
Region
Japan

Condition
Condition Adenoid cystic carcinoma
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to evaluate histological subtypes as prognostic factors of head and neck adenoid cystic carcinoma (ACC) treated with carbon-ion radiotherapy (C-ion RT).
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 adenoid cystic carcinoma.
The patients had medically inoperable tumors or declined surgery.
Key exclusion criteria with active other carcinoma
Target sample size 100

Research contact person
Name of lead principal investigator Masashi Koto
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 Masashi Koto
Organization National Institute of Radiological Science Hospital, National Institutes for Quantum and Radiologica
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 Self funding
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 11 Month 01 Day

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 10 Month 27 Day
Anticipated trial start date
2016 Year 10 Month 28 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 10 Month 27 Day
Last modified on
2016 Year 10 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028299

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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