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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001505
Receipt No. R000001815
Scientific Title The phase II study of hypo-fractionated proton beam therapy for mucosal melanoma of the head and neck
Date of disclosure of the study information 2009/07/03
Last modified on 2015/11/13

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Basic information
Public title The phase II study of hypo-fractionated proton beam therapy for mucosal melanoma of the head and neck
Acronym MM proton P-II
Scientific Title The phase II study of hypo-fractionated proton beam therapy for mucosal melanoma of the head and neck
Scientific Title:Acronym MM proton P-II
Region
Japan

Condition
Condition Mucosal melanoma of the head and neck
Classification by specialty
Dermatology Oto-rhino-laryngology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify a clinical profile of proton beam therapy for mucosal 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
Acute toxicity
Late toxicity

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 Proton beam therapy 60GyE/15fr/5w
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Histologically confirmed mucosal melanoma
2.nasal or paranasal mucosal melanoma
3.N0 and M0
4.PS(ECOG):0-2
5.adequate organ function
Key exclusion criteria 1.with active other carcinoma
2.with mental disorder
3.recieve systemic steroid therapy
4.with active infectious disease
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sadamoto Zenda
Organization National Cancer Center Hospital East
Division name Division of Radiation Oncology
Zip code
Address 6-5-1 Kashiwanoha Kashiwa chiba, Japan
TEL 04-7133-1111
Email szenda@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sadamoto Zenda
Organization National Cancer Center Hospital East
Division name Division of Radiation Oncology
Zip code
Address 6-5-1 Kashiwanoha Kashiwa Chiba
TEL 04-7133-1111
Homepage URL
Email szenda@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Division of Radiation Oncology
Institute
Department

Funding Source
Organization Self funding
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
2009 Year 07 Month 03 Day

Related information
URL releasing protocol
Publication of results Published

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
2008 Year 06 Month 13 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2015 Year 07 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
2008 Year 11 Month 13 Day
Last modified on
2015 Year 11 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001815

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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