UMIN-CTR Clinical Trial

Basic information
Public title	A Retrospective Study for Mucosal Malignant Melanoma of the Head and Neck treated with Carbon-ion Radiotherapy Combined with DAV Chemotherapy
Acronym	Carbon-ion Radiotherapy Combined with DAV Chemotherapy for Mucosal Malignant Melanoma of the Head and Neck
Scientific Title	A Retrospective Study for Mucosal Malignant Melanoma of the Head and Neck treated with Carbon-ion Radiotherapy Combined with DAV Chemotherapy
Scientific Title:Acronym	Carbon-ion Radiotherapy Combined with DAV Chemotherapy for Mucosal Malignant Melanoma of the Head and Neck
Region	Japan

Condition
Condition	Mucosal Malignant Melanoma of the Head and Neck
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of Carbon-ion radiotherapy combined with DAV chemotherapy for 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	Local control rate
Key secondary outcomes	Overall survival rate

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	15 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) histologically confirmed mucosal malignant melanoma of the head and neck, 2) N0M0, 3) inoperable tumor, 4) age between 15 and 80 years, 5) Performance status score <2, 6) grossly measurable tumor.
Key exclusion criteria	1) prior radiotherapy to the Carbon-ion radiotherapy treated area, 2) serious medical or psychological conditions precluding the safe administration of treatment.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Ryo Middle name Last name Takagi
Organization	National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Sciences and Technology
Division name	Hospital
Zip code	263-8555
Address	4-9-1 Anagawa, Inage-ku 263-8555 Chiba, Japan
TEL	043-206-3306
Email	rtakagi@tdc.ac.jp

Public contact
Name of contact person	1st name izumi Middle name Last name Kaneko
Organization	National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Scienc
Division name	Hospital
Zip code	263-8555
Address	4-9-1 Anagawa, Inage-ku Chiba, Japan
TEL	043-206-3306
Homepage URL
Email	helsinki@qst.go.jp

Sponsor
Institute	National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Sciences and Technology
Institute
Department

Funding Source
Organization	National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Sciences and Technology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Sciences and Technology
Address	4-9-1 Anagawa, Inage-ku 263-8555 Chiba, Japan
Tel	043-206-3306
Email	helsinki@qst.go.jp

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	2018 Year 04 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	141
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 10 Day
Date of IRB	2018 Year 01 Month 10 Day
Anticipated trial start date	2018 Year 04 Month 15 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The subjects were treated in April 2001 to March 2016 in patients with mucosal malignant melanoma of the head and neck.

Management information
Registered date	2018 Year 04 Month 11 Day
Last modified on	2020 Year 10 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036720