UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033862 |
|---|---|
| Receipt number | R000038617 |
| Scientific Title | Feasibility study of Carbon-Ion Radiotherapy for Re-Irradiation of Locoregionally Recurrent Head and Neck Tumors |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2019/04/24 07:25:05 |
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Basic information
Public title
Feasibility study of Carbon-Ion Radiotherapy for Re-Irradiation of Locoregionally Recurrent Head and Neck Tumors
Acronym
Carbon-Ion Radiotherapy for Re-Irradiation
Scientific Title
Feasibility study of Carbon-Ion Radiotherapy for Re-Irradiation of Locoregionally Recurrent Head and Neck Tumors
Scientific Title:Acronym
Carbon-Ion Radiotherapy for Re-Irradiation
Region
| Japan |
Condition
Condition
recurrent head and neck tumors
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the toxicity and efficacy of re-irradiation with CIRT for locoregionally recurrent head and neck tumors
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Toxicity
Key secondary outcomes
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
| 1 | years-old | <= |
Age-upper limit
| 999 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) patients who received re-irradiation with CIRT
2) measurable tumors
3) a performance status of 0-2
4) no systemic therapy, such as chemotherapy, within 1 month of commencing re-irradiation with CIRT
5) an estimated life expectancy of more than 6 months
Key exclusion criteria
The presence of other primary cancers
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Ikawa |
Organization
National Institutes for Quantum and Radiological Sciences and Technology
Division name
Hospital of the National Institute of Radiological Sciences
Zip code
Address
Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
TEL
043-206-3360
gbbd16cm@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Hayashi |
Organization
National Institutes for Quantum and Radiological Sciences and Technology
Division name
Hospital of the National Institute of Radiological Sciences
Zip code
Address
Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
TEL
043-206-3360
Homepage URL
gbbd16cm@hotmail.com
Sponsor or person
Institute
Hospital of the National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Sciences and Technology
Institute
Department
Personal name
Funding Source
Organization
Hospital of the National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Sciences and Technology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.thegreenjournal.com/article/S0167-8140(19)30359-7/fulltext
Number of participants that the trial has enrolled
48
Results
The median follow-up period after re-irradiation was 27.1 months. Five patients (10.4%) developed Grade 3 acute toxicities and 18 (37.5%) developed Grade 3-5 late toxicities, including Grade 5 central nervous system necrosis in one patient. The 2-year local control, locoregional control, progression-free survival, and overall survival rates were 40.5, 33.5%, 29.4%, and 59.6%, respectively.
Results date posted
| 2019 | Year | 04 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 07 | Month | 01 | Day |
Baseline Characteristics
Participant flow
Adverse events
Five patients (10.4%) developed Grade 3 acute toxicities and 18 (37.5%) developed Grade3-5 late toxicities, including Grade 5 central nervous system necrosis in one patient.
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2018 | Year | 08 | Month | 23 | Day |
Last modified on
| 2019 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038617
