UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006202 |
|---|---|
| Receipt number | 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 11:02:09 |
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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
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
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007320
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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