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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032199
Receipt No. R000036720
Scientific Title A Retrospective Study for Mucosal Malignant Melanoma of the Head and Neck treated with Carbon-ion Radiotherapy Combined with DAV Chemotherapy
Date of disclosure of the study information 2018/04/15
Last modified on 2018/04/11

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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
Middle name
Last name Ryo Takagi
Organization National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Sciences and Technology
Division name Hospital
Zip code
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
Middle name
Last name Office of the hospital
Organization National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Scienc
Division name Hospital
Zip code
Address 4-9-1 Anagawa, Inage-ku 263-8555 Chiba, Japan
TEL 043-206-3306
Homepage URL
Email rtakagi@tdc.ac.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
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
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
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 No longer recruiting
Date of protocol fixation
2018 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 15 Day
Last follow-up date
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
2018 Year 04 Month 11 Day


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

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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