UMIN-CTR Clinical Trial

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
Last 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
Email	tsuji.hiroshi@qst.go.jp

Public contact
1st 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
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

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025673