UMIN-CTR Clinical Trial

Basic information
Public title	Optimal irradiation field setting and prescribed dose in carbon-ion radiotherapy for sinonasal mucosal melanoma
Acronym	carbon-ion radiotherapy for sinonasal mucosal melanoma
Scientific Title	Optimal irradiation field setting and prescribed dose in carbon-ion radiotherapy for sinonasal mucosal melanoma
Scientific Title:Acronym	carbon-ion radiotherapy for sinonasal mucosal melanoma
Region	Japan

Condition
Condition	Sinonasal mucosal melanoma
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to determine the optimal irradiation field setting and prescribed dose in carbon-ion radiotherapy for sinonasal mucosal melanoma.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relationship between local recurrence site, irradiation field, and prescribed dose.
Key secondary outcomes	Local control rate, overall survival rate, progression-free survival rate, late adverse event occurrence 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	Sinonasal Mucosal melanoma patients who were prospectively enrolled in in-hospital treatment protocols 0007 and 0007 (2) from July 2001 to February 2018 and were treated with carbon-ion radiotherapy combined with DAV chemotherapy, which is a protocol treatment.
Key exclusion criteria	Refusal of use of clinical data for this study by the study subject or his / her agent.
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Masashi Middle name Last name Koto
Organization	National Institutes for Quantum Sciences and Technology
Division name	QST Hospital
Zip code	263-8555
Address	4-9-1 Anagawa Inage Chiba
TEL	043-206-3306
Email	koto.masashi@qst.go.jp

Public contact
Name of contact person	1st name Masashi Middle name Last name Koto
Organization	National Institutes for Quantum Sciences and Technology
Division name	QST Hospital
Zip code	263-8555
Address	4-9-1 Anagawa Inage Chiba
TEL	043-206-3306
Homepage URL
Email	koto.masashi@qst.go.jp

Sponsor
Institute	National Institutes for Quantum Sciences and Technology
Institute
Department

Funding Source
Organization	National Institutes for Quantum 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 Institutes for Quantum Sciences and Technology
Address	4-9-1 Anagawa Inage Chiba
Tel	043-206-4706
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	2021 Year 09 Month 30 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	135
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	2021 Year 09 Month 09 Day
Date of IRB	2021 Year 09 Month 17 Day
Anticipated trial start date	2021 Year 09 Month 17 Day
Last follow-up date	2022 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2021 Year 09 Month 29 Day
Last modified on	2022 Year 09 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052059