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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000006202
Receipt No. R000007320
Scientific Title Efficacy of FLT-PET assesment in treating head and neck cancer with chemoradiation
Date of disclosure of the study information 2011/09/01
Last modified on 2012/02/23

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Basic information
Public title Efficacy of FLT-PET assesment in treating head and neck cancer with chemoradiation
Acronym FLT-PET for head and neck cancer treated with CRT
Scientific Title Efficacy of FLT-PET assesment in treating head and neck cancer with chemoradiation
Scientific Title:Acronym FLT-PET for head and neck cancer treated with CRT
Region
Japan

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

Objectives
Narrative objectives1 To investigate the efficacy of FLT-PET to predict the response of chemoradiation for head and neck cancer in the early stage of the treatrment
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes TO investigate that the change of FLT uptake between pre-treatment and after 10-20Gy radiation correlates with the response of chemoradiation for head and neck cancer
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 Prevention
Type of intervention
Medicine Device,equipment
Interventions/Control_1 FLT-PET
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.Patients with untreated oropharyngeal, hypopharyngeal or laryngeal squamous cell carcinoma
2. Stage 3 or more
3. Patients with a primary lesion of 2cm or more in diameter
Key exclusion criteria 1. Poor general condition
2. Cannot keep supine position for 60 minutes
3. Pregnant or possibility of pregnancy
4. Severe claustrophobia
5. Regarded as unsuitable by responsible investigators
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shogo Shinohara
Organization Kobe City Medical Center General Hospital
Division name Otolaryngology and Hed and Neck Surgery
Zip code
Address Minatojimaminamimachi 2-1-1, Chuo-Ku, Kobe
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Kikuchi
Organization Kobe City Medical Center General Hospital
Division name Otolaryngology and Hed and Neck Surgery
Zip code
Address Minatojimaminamimachi 2-1-1, Chuo-Ku, Kobe
TEL
Homepage URL
Email

Sponsor
Institute Kobe City Medical Center General Hospital
Institute
Department

Funding Source
Organization Foundation of Biomedical Research and Innovation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor Foundation of Biomedical Research and Innovation
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
2011 Year 09 Month 01 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 Terminated
Date of protocol fixation
2011 Year 08 Month 08 Day
Date of IRB
Anticipated trial start date
2011 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 08 Month 19 Day
Last modified on
2012 Year 02 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007320

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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