UMIN-CTR Clinical Trial

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