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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031715
Receipt No. 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 2018/03/14

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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
Email 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
Email tsuji.hiroshi@qst.go.jp

Sponsor
Institute National Institutes for Quantum and Radiological Science and Technology
National Institute of Radiological Sciences
Institute
Department

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
Email

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 Open public recruiting
Date of protocol fixation
2018 Year 03 Month 07 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 14 Day
Last follow-up date
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
2018 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036221

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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