UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022302 |
|---|---|
| Receipt number | R000025673 |
| Scientific Title | Clinical Trial for Hypofractionated (4 Fraction) Heavy Ion Therapy for Ocular / Choroidal Melanoma |
| Date of disclosure of the study information | 2016/05/16 |
| Last modified on | 2019/03/15 09:29:58 |
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Basic information
Public title
Clinical Trial for Hypofractionated (4 Fraction) Heavy Ion Therapy for Ocular / Choroidal Melanoma
Acronym
4 Fraction Heavy Ion Therapy for Ocular / Choroidal Melanoma
Scientific Title
Clinical Trial for Hypofractionated (4 Fraction) Heavy Ion Therapy for Ocular / Choroidal Melanoma
Scientific Title:Acronym
4 Fraction Heavy Ion Therapy for Ocular / Choroidal Melanoma
Region
| Japan |
Condition
Condition
Ocular / Choroidal Melanoma
Classification by specialty
| Ophthalmology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate safety and efficacy of short-term, dose-escalated heavy ion therapy for ocular / choroidal melanoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Normal tissue acute toxicity. (to be evaluated at end of treatment, 3 months and 6 months post-treatment.
Key secondary outcomes
Initial response
Local control rate
Normal tissue late toxicity
Overall survival rate
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
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Treatment period of 4 to 6 days.
Initial dose to be 64Gy(RBE) in 4 fractions.
After 5 cases, dose to be escalated to 68Gy(RBE) in 4 fractions.
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 melanoma.
2. Size of the tumor can be evaluated.
3. Performance Status (ECOG) is between 0-2
4. Any patient who posses ability to consent. Patients below 20 y.o must possess the ability to fully comprehend their disease and treatment options and assent to participate in this study on written matter alongside with consent of the guardian(s).
Key exclusion criteria
1. Existence of past treatment against the lesion.
2. Existence of extra-ocular lesion including metastasis.
3. Life expectancy shorter than 6 months
4. Active infection within the irradiation field
5. Existence of other active malignancies.
6. Existence of severe complications
7. Evaluated not able to complete this study because of serious medical or psychological problems
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Tsuji |
Organization
National Institutes for Quantum and Radiological Science and Technology
Division name
National Institute of Radiological Sciences Hospital
Zip code
Address
4-9-1 Anagawa, Inage-ku, Chiba 263-8555, Japan
TEL
043-206-3350
tsuji.hiroshi@qst.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Tsuji |
Organization
National Institutes for Quantum and Radiological Science and Technology
Division name
National Institute of Radiological Sciences Hospital
Zip code
Address
4-9-1 Anagawa, Inage-ku, Chiba 263-8555, Japan
TEL
043-206-3350
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
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
放射線医学総合研究所(千葉県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 16 | 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
| 2016 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 16 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 13 | Day |
Last modified on
| 2019 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025673
