UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031715 |
|---|---|
| Receipt number | R000036221 |
| Scientific Title | Evaluation of the Safety of Scanning Beam Carbon-ion Therapy for Ocular / Choroidal Malignant Melanoma |
| Date of disclosure of the study information | 2018/03/14 |
| Last modified on | 2023/09/19 19:18:36 |
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Basic information
Public title
Evaluation of the Safety of Scanning Beam Carbon-ion Therapy for Ocular / Choroidal Malignant Melanoma
Acronym
Evaluation of Scanning Beam Carbon-ion Therapy for Ocular / Choroidal Malignant Melanoma
Scientific Title
Evaluation of the Safety of Scanning Beam Carbon-ion Therapy for Ocular / Choroidal Malignant Melanoma
Scientific Title:Acronym
Evaluation of Scanning Beam Carbon-ion Therapy for Ocular / Choroidal Malignant Melanoma
Region
| Japan |
Condition
Condition
Ocular / Choroidal Malignant Melanoma
Classification by specialty
| Ophthalmology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of scanning beam carbon-ion therapy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Acute normal tissue toxicity
Key secondary outcomes
Local control rate, late normal tissue toxicity, overal survival, eye retention rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Carbon-ion therapy will be delivered by scanning beam technology in 4 fractions at 17Gy (RBE) per fraction (total dose 68Gy (RBE)). First 15 cases will be planned by Single Field Uniform Dose planning, where the later 15 cases will be also planned by Multi-Field Sequential Optimization or Intensity Modulated Particle Therapy and compared with Single Field Uniform Dose.
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. Clinically diagnosed Ocular / Choroidal Malignant Melanoma.
2. Tumor measurable by imaging tests.
3. Performance Status (ECOG) 0-2
4. Capable of giving consent to treatment. Minors are required to have consent from their guardians also.
Key exclusion criteria
1. Evidence of extra-orbital lesion.
2. Presumed life expectancy to be less than 6 months.
3. Active treatment-resistant infection within the irradiation field.
4. Active co-existing malignancy.
5. Severe coexisting disease.
6. Clinically unfit to complete the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | TSUJI, Hiroshi |
Organization
National Institutes for Quantum and Radiological Sciences and Technology
National Institute of Radiological Sciences
Division name
Clinical Research Cluster
Zip code
Address
Anagawa 4-Choume 9-1, Inage, Chiba 2638555
TEL
043-206-3306
tsuji.hiroshi@qst.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | TSUJI, Hiroshi |
Organization
National Institutes for Quantum and Radiological Sciences and Technology, National Institute of Radi
Division name
Clinical Research Cluster
Zip code
Address
Anagawa 4-Choume 9-1, Inage, Chiba 2638555
TEL
043-206-3306
Homepage URL
tsuji.hiroshi@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum and Radiological Science and Technology
National Institute of Radiological Sciences
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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
国立研究開発法人量子科学研究開発機構 放射線医学総合研究所（千葉県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 14 | 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
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 14 | Day |
Last modified on
| 2023 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036221
| 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 |
