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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023830
Receipt No. R000027417
Scientific Title radiation therapy planning with PET-CT for head and neck cancer
Date of disclosure of the study information 2016/08/31
Last modified on 2019/03/05

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Basic information
Public title radiation therapy planning with PET-CT for head and neck cancer
Acronym radiation therapy planning with PET-CT for head and neck cancer
Scientific Title radiation therapy planning with PET-CT for head and neck cancer
Scientific Title:Acronym radiation therapy planning with PET-CT for head and neck cancer
Region
Japan

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

Objectives
Narrative objectives1 To evaluate safety and efficacy of radiation therapy planning using PET-CT for head and neck cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Adverse effect rate
Key secondary outcomes Recurrence rate
Completion rate of radiation therapy
Compliance rate for dose constrain

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
Device,equipment
Interventions/Control_1 Make IMRT planning based on FDG-PET-CT performed with immobilization shell.
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. pathologically confirmed head and neck squamous cell cancer
2. planned to receive definitive radiotherapy with or with out chemotherapy
3. Performance Status(ECOG)0-2
4. obtained informed consent by document
Key exclusion criteria 1. without prophylactic neck irradiation
2. with distal metastasis
3. inappropriate for PET-CT
4. previously received head and neck irradiation
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuma Toda
Organization Tokyo medical and dental university
Division name Radiation Therapeutics and Oncology
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo ,JAPAN
TEL 03-5803-5311
Email tdmrad@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuma Toda
Organization Tokyo medical and dental university
Division name Radiation Therapeutics and Oncology
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo ,JAPAN
TEL 03-5803-5311
Homepage URL
Email tdmrad@tmd.ac.jp

Sponsor
Institute Tokyo medical and dental university
Institute
Department

Funding Source
Organization Tokyo medical and dental university
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 東京医科歯科大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 31 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 Enrolling by invitation
Date of protocol fixation
2016 Year 08 Month 19 Day
Date of IRB
Anticipated trial start date
2016 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
2016 Year 08 Month 29 Day
Last modified on
2019 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027417

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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