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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033007
Receipt No. R000037631
Scientific Title Study of efficacy and safety of dose reduction in the oral cavity by target volume definition using PET/CT for intensity-modulated radiation therapy of head and neck cancers
Date of disclosure of the study information 2018/06/16
Last modified on 2019/06/04

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Basic information
Public title Study of efficacy and safety of dose reduction in the oral cavity by target volume definition using PET/CT for intensity-modulated radiation therapy of head and neck cancers
Acronym Study of efficacy and safety of dose reduction in the oral cavity by target volume definition using PET/CT for intensity-modulated radiation therapy of head and neck cancers
Scientific Title Study of efficacy and safety of dose reduction in the oral cavity by target volume definition using PET/CT for intensity-modulated radiation therapy of head and neck cancers
Scientific Title:Acronym Study of efficacy and safety of dose reduction in the oral cavity by target volume definition using PET/CT for intensity-modulated radiation therapy of head and neck cancers
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 and safety of determining the target volume using PET/CT, which allows imaging at the posture assumed at the time of radiation therapy, when planning an intensity-modulated radiation treatment for head and neck cancer patients whose lesions extend to the level of the oral cavity.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The target volume (at the oral cavity level) defined by PET/CT and the radiation dose in the oral cavity
Key secondary outcomes Acute and late adverse events during and after the radiation therapy
The presence or absence of local recurrence and distant metastasis during the 3-year post-treatment period, and overall survival

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Patients whose target volume is defined by PET/CT and in whom radiation therapy is performed according to the defined planning target volume
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 Patients with head neck cancer who meet all of the following criteria;
1.Age over 20
2.Pathologically confirmed head neck cancer
3.The neck (at the oral cavity level) will be irradiated with a dose of 50Gy or higher
4.Performance status (ECOG) 0-2
5.Written informed consent
Key exclusion criteria 1.Patients have psychiatric disorders that may comprise the patient's ability to receive radiotherapy
2.Patients who is considered ineligible for enrolling the study by a principal investigator or sub-investigator
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Sasai
Middle name
Last name Keisuke
Organization Juntendo University
Division name Department of Radiation Oncology
Zip code 113-8431
Address Tokyo
TEL +81338133111
Email ykosugi@juntendo.ac.jp

Public contact
Name of contact person
1st name Kosugi
Middle name
Last name Yasuo
Organization Juntendo University
Division name Department of Radiation Oncology
Zip code 113-8431
Address Tokyo
TEL +81338133111
Homepage URL
Email ykosugi@juntendo.ac.jp

Sponsor
Institute Juntendo University,Graduate School of Medicine,Department of Radiation Oncology
Institute
Department

Funding Source
Organization Juntendo University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Juntendo Clinical Research and Trial Center
Address 3-1-3 hongo,Bunkyo,Tokyo
Tel 03-5802-1584
Email kenkyu58585@juntendo.ac.jp

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
2018 Year 06 Month 16 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 Open public recruiting
Date of protocol fixation
2018 Year 03 Month 05 Day
Date of IRB
2018 Year 05 Month 31 Day
Anticipated trial start date
2018 Year 06 Month 15 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 15 Day
Last modified on
2019 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037631

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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