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Evaluation of the Safety of Scanning Beam Carbon-ion Therapy for Ocular / Choroidal Malignant Melanoma

Evaluation of the Safety of Scanning Beam Carbon-ion Therapy for Ocular / Choroidal Malignant Melanoma - Evaluation of Scanning Beam Carbon-ion Therapy for Ocular / Choroidal Malignant Melanoma

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000031715
Enrollment
30
Registered
2018-03-14
Start date
2018-03-14
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 Malignant Melanoma

Interventions

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

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 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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Acute normal tissue toxicity—

Secondary

MeasureTime frame
Local control rate, late normal tissue toxicity, overal survival, eye retention rate—

Countries

Japan

Contacts

Public ContactTSUJI, Hiroshi

National Institutes for Quantum and Radiological Sciences and Technology, National Institute of Radi Clinical Research Cluster

tsuji.hiroshi@qst.go.jp043-206-3306

Outcome results

None listed

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