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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001579
Receipt No. R000001902
Scientific Title The dermatitis control program for head and neck cancer patients treated with radiotherapy -prospective phase II study-
Date of disclosure of the study information 2009/02/01
Last modified on 2012/10/19

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Basic information
Public title The dermatitis control program for head and neck cancer patients treated with radiotherapy -prospective phase II study-
Acronym Decop-01
Scientific Title The dermatitis control program for head and neck cancer patients treated with radiotherapy -prospective phase II study-
Scientific Title:Acronym Decop-01
Region
Japan

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

Objectives
Narrative objectives1 To clarify the dermatitis control program is useful for head and neck cancer patients treated with radiotherapy to prevent fatal dermatitis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Frequency of grade 4 dermatitis
Key secondary outcomes Frequency of grade 3 dermatitis
Dermatitis recovery period

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 The dermatitis control program
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1.Head and neck cancer patients who are to be treated with RT
2.No prior treatment
3.PS(ECOG) 0-2
4.Written in IC
Key exclusion criteria 1.With mental disorder
2.Recieve systemic streroid therapy
Target sample size 120

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
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization National Cancer Center Hospital East
Division name Division of Radiation Oncology
Zip code
Address
TEL
Homepage URL
Email szenda@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization Now finding
Organization
Division
Category of Funding Organization Non profit foundation
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 02 Month 01 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 12 Month 12 Day
Date of IRB
Anticipated trial start date
2009 Year 02 Month 01 Day
Last follow-up date
2010 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
2010 Year 11 Month 01 Day
Date analysis concluded
2010 Year 11 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 12 Month 16 Day
Last modified on
2012 Year 10 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001902

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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