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Clinical Trial for Hypofractionated (4 Fraction) Heavy Ion Therapy for Ocular / Choroidal Melanoma

Clinical Trial for Hypofractionated (4 Fraction) Heavy Ion Therapy for Ocular / Choroidal Melanoma - 4 Fraction Heavy Ion Therapy for Ocular / Choroidal Melanoma

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000022302
Enrollment
30
Registered
2016-05-16
Start date
2016-05-16
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular / Choroidal Melanoma

Interventions

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.

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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).

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Normal tissue acute toxicity. (to be evaluated at end of treatment, 3 months and 6 months post-treatment.

Secondary

MeasureTime frame
Initial response Local control rate Normal tissue late toxicity Overall survival rate Eye retention rate

Countries

Japan

Contacts

Public ContactHiroshi Tsuji

National Institutes for Quantum and Radiological Science and Technology National Institute of Radiological Sciences Hospital

tsuji.hiroshi@qst.go.jp043-206-3350

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026