UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043915 |
|---|---|
| Receipt number | R000050151 |
| Scientific Title | Retrospective analysis of carbon ion radiation therapy for local recurrence after head and neck cancer reconstruction |
| Date of disclosure of the study information | 2021/04/15 |
| Last modified on | 2021/04/13 19:20:46 |
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Basic information
Public title
Retrospective analysis of carbon ion radiation therapy for local recurrence after head and neck cancer reconstruction
Acronym
Retrospective analysis of carbon ion radiation therapy for local recurrence after head and neck cancer reconstruction
Scientific Title
Retrospective analysis of carbon ion radiation therapy for local recurrence after head and neck cancer reconstruction
Scientific Title:Acronym
Retrospective analysis of carbon ion radiation therapy for local recurrence after head and neck cancer reconstruction
Region
| Japan |
Condition
Condition
Head and neck cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will analyze the treatment results and prognosis of carbon ion radiation therapy performed for local recurrence after postoperative reconstruction of head and neck cancer, and examine its safety and efficacy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Local control rate, progression-free survival rate, overall survival rate
Key secondary outcomes
Frequency of side effects of reconstructed tissue
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Tumor diameter can be measured.
PS is 2 or less.
Key exclusion criteria
Re-irradiation using carbon ions for recurrent after carbon-ion radiotherapy.
Target sample size
30
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, Chiba-city.
TEL
043-206-3306
ikawahiroaki@tdc.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, Chiba-city.
TEL
043-206-3306
Homepage URL
ikawahiroaki@tdc.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
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Review Committee Secretariat
Address
4-9-1, Anagawa, Inage, Chiba-city.
Tel
043-206-4709
helsinki@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
| 2021 | Year | 04 | Month | 15 | 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
30
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 04 | Month | 06 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2021 | Year | 04 | Month | 13 | Day |
Last modified on
| 2021 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050151
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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