UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037119 |
|---|---|
| Receipt number | R000042294 |
| Scientific Title | Effects of different breathing methods on dose distribution in carbon ion radiotherapy for head and neck cancer |
| Date of disclosure of the study information | 2019/06/30 |
| Last modified on | 2019/06/19 20:24:35 |
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Basic information
Public title
Effects of different breathing methods on dose distribution in carbon ion radiotherapy for head and neck cancer
Acronym
Effects of different breathing methods on dose distribution in carbon ion radiotherapy for head and neck cancer
Scientific Title
Effects of different breathing methods on dose distribution in carbon ion radiotherapy for head and neck cancer
Scientific Title:Acronym
Effects of different breathing methods on dose distribution in carbon ion radiotherapy for head and neck cancer
Region
| Japan |
Condition
Condition
head and neck cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will clarify the effects of different breathing methods by mouth breathing and nasal breathing on dose distribution in head and neck cancer patients undergoing carbon ion radiotherapy at QST hospital.
Basic objectives2
Others
Basic objectives -Others
In this study, we will clarify the effects of different breathing methods by mouth breathing and nasal breathing on dose distribution in head and neck cancer patients undergoing carbon ion radiotherapy at QST hospital.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dose to tongue and soft palate, dose to risk organs such as pharyngeal mucosa and spinal cord, dose to gross tumor volume and planned target volume in DVH analysis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Mouth breathe
Interventions/Control_2
Nose breathe
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Histologically confirmed head and neck cancer
Patients who undergo carbon ion radiotherapy in QST hospital
patients who are expected to include the soft palate and tongue in the radiation field.
patients who cannnot use the tongue depressor
Key exclusion criteria
Other medical or psychological unsuitable reasons
There are significant metal artifacts on the treatment planning CT images.
Patients with nasal cavity or oral cavity who have difficulty breathing with either nasal or mouth breathing.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Ikawa |
Organization
National Institutes for Quantum and Radiological Science and Technology
Division name
QST Hospital
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba, 263-8555, Japan.
TEL
043-206-3306
ikawa.hiroaki@qst.go.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Ikawa |
Organization
National Institutes for Quantum and Radiological Science and Technology
Division name
QST Hospital
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba, 263-8555, Japan.
TEL
043-206-3306
Homepage URL
ikawa.hiroaki@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum and Radiological Science and Technology
Institute
Department
Personal name
Funding Source
Organization
National Institutes for Quantum and Radiological Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institutes for Quantum and Radiological Science and Technology
Address
4-9-1 Anagawa, Inage-ku, Chiba, 263-8555, Japan.
Tel
043-206-3306
ikawa.hiroaki@qst.go.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
| 2019 | Year | 06 | Month | 30 | 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
| 2019 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | 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
| 2019 | Year | 06 | Month | 20 | Day |
Last modified on
| 2019 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042294
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
