UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059208 |
|---|---|
| Receipt number | R000067715 |
| Scientific Title | A Prospective Study on Selective Field Expansion During Carbon-ion Radiotherapy for Head and Neck Adenoid Cystic Carcinoma |
| Date of disclosure of the study information | 2025/11/01 |
| Last modified on | 2025/09/26 17:11:16 |
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Basic information
Public title
A Prospective Study on Selective Field Expansion During Carbon-ion Radiotherapy for Head and Neck Adenoid Cystic Carcinoma
Acronym
Selective Field Expansion During Carbon-ion Radiotherapy for Head and Neck Adenoid Cystic Carcinoma
Scientific Title
A Prospective Study on Selective Field Expansion During Carbon-ion Radiotherapy for Head and Neck Adenoid Cystic Carcinoma
Scientific Title:Acronym
A Prospective Study on Selective Field Expansion During Carbon-ion Radiotherapy for Head and Neck Adenoid Cystic Carcinoma
Region
| Japan |
Condition
Condition
Head and Neck Adenoid Cystic Carcinoma
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to examine the impact of differences in Carbon-ion Radiotherapy treatment planning based on the presence or absence of perineural tumor spread (PNTS) in patients with head and neck adenoid cystic carcinoma on local control and treatment-related adverse events.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
5-year Local Control Rate
Key secondary outcomes
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
The radiation field is defined not only based on the gross tumor volume (GTV) confirmed radiologically on CT and MRI scans taken during treatment planning, but also considering high-risk anatomical structures adjacent to the tumor site that adenoid cystic carcinoma is known to readily invade (e.g., nerve, muscle, and bone tissue spaces). The GTV is targeted for the full planned treatment dose (64 or 57.6 Gy RBE; Relative Biological Effectiveness), and a margin is added to establish the clinical target volume (CTV).CTV is defined in two stages (CTV1: first half, CTV2: second half). For the PNTS (-) group, the conventional treatment plan of 36 GyRBE in the first half is applied, with the GTV + 5 mm margin defined as CTV1. Conversely, for the PNTS (+) group, CTV1 is defined by adding an additional +5 mm margin toward the central region beyond the aforementioned range. The remaining dose for the second half (28 GyRBE for a total dose of 64 GyRBE, or 21.6 GyRBE for a total dose of 57.6 GyRBE) is defined as CTV2 for all cases, regardless of PNTS status, by adding a 3 mm margin to the GTV. The planning target volume (PTV) is defined by adding a 2 mm margin to both CTV1 and CTV2.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with histologically confirmed adenoid cystic carcinoma of the head and neck region.
2) Patients with measurable lesions.
3) Patients scheduled to undergo Carbon-ion Radiotherapy.
4) Patients aged 18 years or older.
5) Patients with a Performance Status (PS) of 0-2.
6) Patients who have been informed of their diagnosis and condition and possess the capacity to consent.
Key exclusion criteria
1) Patients with a history of radiation therapy to the target treatment area.
2) Patients with active, refractory infection at the irradiation site.
3) Patients with severe complications (e.g., poorly controlled diabetes, myocardial infarction requiring urgent intervention, unstable angina, poorly controlled arrhythmia, bleeding tendency due to untreated hemorrhagic disease, collagen disease requiring steroid administration).
4) Patients with active multiple cancers (synchronous multiple cancers and metachronous multiple cancers with a disease-free interval of 5 years or less). However, lesions equivalent to carcinoma in situ or mucosal carcinoma, deemed curable by local therapy, are not included in active multiple cancers.
5) Other individuals deemed unsuitable by the attending physician due to medical, psychological, or other factors.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Musha |
Organization
Gunma University
Division name
Heavy Ion Medical Center
Zip code
371-8511
Address
3-39-22 Showa-machi, Maebashi, Japan
TEL
027-220-8378
musha@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Musha |
Organization
Gunma University
Division name
Heavy Ion Medical Center
Zip code
371-8511
Address
3-39-22 Showa-machi, Maebashi, Japan
TEL
027-220-8378
Homepage URL
musha@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
none
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
Gunma University Hospital Clinical Research Review Board
Address
3-39-15 Showa-machi, Maebashi, Japan
Tel
027-220-8740
irb-jimukk-ciru@ml.gunma-u.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
| 2025 | Year | 11 | Month | 01 | 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
| 2025 | Year | 09 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2036 | Year | 05 | 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
| 2025 | Year | 09 | Month | 26 | Day |
Last modified on
| 2025 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067715
