UMIN-CTR Clinical Trial

Basic information
Public title	Prospective study of efficacy and safety of carbon ion radiotherapy combined with chemotherapy for head and neck melanoma
Acronym	Carbon ion radiotherapy combined with chemotherapy for head and neck melanoma
Scientific Title	Prospective study of efficacy and safety of carbon ion radiotherapy combined with chemotherapy for head and neck melanoma
Scientific Title:Acronym	Carbon ion radiotherapy combined with chemotherapy for head and neck melanoma
Region	Japan

Condition
Condition	Head and neck melanoma
Classification by specialty	Oto-rhino-laryngology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To confirm efficacy and safety of carbon ion radiotherapy combined with chemotherapy for head and neck melanoma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overall survival rate at 3 years
Key secondary outcomes

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	Medicine Maneuver
Interventions/Control_1	Carbon ion radiotherapy combined with chemotherapy
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	16 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Histologically confirmed head and neck melanoma 2) N0M0 (UICC 7th) 3) Measurable tumor 4) Age 16-80 5) No severe organ dysfunction 6) PS 0-2 7) Informed consent was given
Key exclusion criteria	1) Past history of irradiation to the target 2) Past history of chemotherapy before treatment 3) Uncontrolled infection 4) Severe concomitant disease 5) Active double cancers 6) Other medical or psychological unsuitable reasons
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takashi Nakano
Organization	Gunma University
Division name	Gunma University Heavy Ion Medical Center
Zip code
Address	3-39-22 Showa, Maebashi, Gunma 371-8511
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	Gunma University
Division name	Gunma University Heavy Ion Medical Center
Zip code
Address
TEL	027-220-8378
Homepage URL
Email

Sponsor
Institute	Gunma University Heavy Ion Medical Center
Institute
Department

Funding Source
Organization	MEXT
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2012 Year 05 Month 13 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
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	2012 Year 02 Month 13 Day
Date of IRB	2012 Year 03 Month 29 Day
Anticipated trial start date	2012 Year 04 Month 01 Day
Last follow-up date	2019 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 05 Month 13 Day
Last modified on	2019 Year 10 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009349