UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II study of carbon-ion radiotherapy combined with anti-tumor agents for mucosal malignant melanoma of the head and neck
Title of the study (Brief title)	Carbon-ion therapy for malignant melanoma of the head and neck (iROCK-1603HN)
Region	Japan

Condition
Condition	mucosal malignant melanoma of the 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 mucosal malignant melanoma of the head and neck.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	3-year survival rate
Key secondary outcomes	1) Local control rate 2) Disease-specific survival 3) Early and late adverse event rate 4) Local response rate

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

Eligibility
Age-lower limit	15 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Mucosal malignant melanoma of head and neck which is pathologically or cytologically diagnosed 2) Patient without lymph node metastasis (N0) and no remote metastasis(M0) 3) Measurable primary lesion 4) 0 to 2 of performance status 5) 15 years or older and 80 years or younger of age 6)Sufficient organ functions 7) 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	1)Patient with past history of radiotherapy for the targeted lesion 2)Patient is within 2 weeks after the final chemoterapy 3)Patient with active double cancer 4)Patients with active and intractable infection in the targeted lesion 5) Patient with metal devices in the lesion 6) Other medical or psychological condition which is unsuitable for carbon-ion therapy
Target sample size	65

Research contact person
Name of lead principal investigator	Dr. Hiroyuki Katoh
Organization	Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Division name	Department of Carbon-ion Radiotherapy
Address	2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
TEL	045-520-2222
Email	hkatoh@kcch.jp

Public contact
Name of contact person	Dr. Hiroyuki Katoh
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
Homepage URL
Email	hkatoh@kcch.jp

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

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

Other related organizations
Co-sponsor	None
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	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 08 Month 01 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 03 Month 09 Day
Anticipated trial start date	2016 Year 08 Month 01 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 07 Month 15 Day
Last modified on	2018 Year 04 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026725

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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