UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033007 |
|---|---|
| Receipt number | 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 12:20:42 |
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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
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
ykosugi@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University,Graduate School of Medicine,Department of Radiation Oncology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037631
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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