UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061473 |
|---|---|
| Receipt number | R000070340 |
| Scientific Title | A Multicenter Retrospective Observational Study of Carbon-ion Radiotherapy for Primary Squamous Cell Carcinoma of the Nasal Cavity and Paranasal Sinuses |
| Date of disclosure of the study information | 2026/05/07 |
| Last modified on | 2026/05/07 13:45:47 |
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Basic information
Public title
A Multicenter Observational Study of Carbon-ion Radiotherapy for Squamous Cell Carcinoma of the Nasal Cavity and Paranasal Sinuses
Acronym
Nasal & Paranasal SCC CIRT Study
Scientific Title
A Multicenter Retrospective Observational Study of Carbon-ion Radiotherapy for Primary Squamous Cell Carcinoma of the Nasal Cavity and Paranasal Sinuses
Scientific Title:Acronym
Nasal & Paranasal SCC CIRT Study
Region
| Japan |
Condition
Condition
Primary Squamous Cell Carcinoma of the Nasal Cavity and Paranasal Sinuses
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of carbon-ion radiotherapy in patients with primary squamous cell carcinoma of the nasal cavity and paranasal sinuses
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary endpoints are local control rate, progression-free survival, and overall survival.
Key secondary outcomes
The secondary endpoint is the grade and incidence of adverse events.
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
1) Histologically confirmed primary squamous cell carcinoma of the nasal cavity or paranasal sinuses.
2) Regional lymph node status of N0-N2 at the start of carbon-ion radiotherapy.
3) No evidence of distant metastasis.
4) Deemed unsuitable for surgical resection of the primary tumor.
5) Received carbon-ion radiotherapy with curative intent.
6) At least one measurable lesion.
7) An Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at the initiation of treatment.
Key exclusion criteria
1) Patients who declined the use of their data after public disclosure of this study (opt-out).
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Shinoto |
Organization
National Institutes for Quantum Science and Technology
Division name
QST Hospital
Zip code
2638555
Address
4-9-1 Anagawa, Ingake-ku, Chiba
TEL
0432063306
shinoto.makoto@qst.go.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Ikawa |
Organization
National Institutes for Quantum Science and Technology
Division name
QST Hospital
Zip code
2638555
Address
4-9-1 Anagawa, Ingake-ku, Chiba
TEL
0432063306
Homepage URL
ikawa.hiroaki@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Science and Technology
Institute
Department
Personal name
Funding Source
Organization
National Institutes for Quantum Science 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
National Institutes for Quantum Science and Technology Certificated Review Board
Address
4-9-1 Anagawa, Ingake-ku, Chiba
Tel
0432064706
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
| 2026 | Year | 05 | Month | 07 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. This is a multicenter retrospective observational study using existing clinical data.
2. Patients who initiated carbon-ion radiotherapy for primary squamous cell carcinoma of the nasal cavity and paranasal sinuses as advanced medical care or under national health insurance between November 2003 and December 2025 will be included.
3. No additional interventions or treatment assignments are performed for this study.
4. Informed consent is waived, and an opt-out approach is applied through public disclosure.
Management information
Registered date
| 2026 | Year | 05 | Month | 07 | Day |
Last modified on
| 2026 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070340
