UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Phase II Study of Carbon-Ion Radiotherapy for Non-Squamous Cell Carcinoma of the Head and Neck
Title of the study (Brief title)	Carbon-Ion Therapy for Non-SCC of Head and Neck Tumor
Region	Japan

Condition
Condition	Non-squamous cell carcinoma of head and neck
Classification by specialty	Oto-rhino-laryngology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of carbon-ion radiotherapy for non-squamous cell carcinoma of head and neck, except for mucosal malignant melanoma and sarcoma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Local control rate at 3 years
Key secondary outcomes	1) Overall survival, Disease-specific survival 2) Early and late adverse event rate 3) Local response rate (primary treatment outcome)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Device,equipment
Interventions/Control_1	A total of 64.0 GyE of carbon-ion radiotherapy, consisting of 16 fractions of 4.0 GyE/ day for 6 to 8 times in 2 weeks
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	15 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	A) Non-squamous cell carcinoma of head and neck which is pathologically or cytologically diagnosed, except for malignant melanoma and sarcoma B) Patient without lymph node metastasis or with clinical stage of N1 which can be treated by the same irradiation field as primary lesion C) Measurable primary lesion D) No remote metastasis E) 0 to 2 of performance status F) 15 years or older and 80 years or younger of age, and 6 months or longer of expected survival G) Patient is able to understand this clinical trial and is informed for the diagnosis and disease status. And patient can be given consent with document after explanation of this trial by study personnel
Key exclusion criteria	A) Past history of radiotherapy for the target lesion B) Less than two weeks after the last administration of chemotherapy C) Active double cancer D) Active and intractable infection in the target lesion E) Metal devices in the target lesion which is not able to be removed F) Patient is not suitable for this study due to medical, psychological or the other reason
Target sample size	54

Research contact person
Name of lead principal investigator	Dr. Takuma Nomiya
Organization	Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Division name	Ion-beam Radiation Oncology Center
Address	2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
TEL	045-520-2222
Email	tnomiya@kcch.jp

Public contact
Name of contact person	Dr. Takuma Nomiya
Organization	Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organizatio
Division name	Ion-beam Radiation Oncology Center
Address	2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
TEL	045-520-2222
Homepage URL
Email	tnomiya@kcch.jp

Sponsor
Institute	Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	None
Name of secondary funｄer(s)	None

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	神奈川県立がんセンター(神奈川県)

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 24 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 03 Month 16 Day
Anticipated trial start date	2016 Year 03 Month 24 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	2016 Year 03 Month 22 Day
Last modified on	2017 Year 06 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024861

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