Clinical trial · Interventional
Hypofractionated Stereotactic Linear Accelerator Radiotherapy of Uveal Melanoma
Safety and Efficacy of Hypofractionated Stereotactic Linear Accelerator Radiotherapy of Malignant Melanoma of the Uvea
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to assess the safety and efficacy of hypofractionated stereotactic LINAC radiotherapy with 10 fractions at 6 Gy per fraction at the 80% isodose for the planning target volume (PTV) in patients with uveal melanoma. Patients will be followed-up for 10 years after radiotherapy regarding local tumor control, visual acuity, secondary complications and survival.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uveal Melanoma | Uveal Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionated linear accelerator radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hypofractionated LINAC radiotherapy
- interventionNames
- Radiation: Hypofractionated linear accelerator radiotherapy
Primary outcomes (1)
- measure
- local tumor control (tumor dimensions; secondary complications; visual acuity; survival
Secondary outcomes (1)
- measure
- histological assessment of the fraction of living cells in eyes requiring secondary enucleation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * The initial height of the melanoma is 7 mm or higher. * Juxtapapillary and/or juxtamacular melanomas with a height of 3 mm or higher and if the central tumor distance to the optic disc and/or the macula is 3 mm or less. * If other forms of conservative treatment of the melanoma are not possible. Exclusion Criteria: * Prior/Concomitant Treatment. * Extrascleral tumor extension is present. * If the presence of neovascular glaucoma is detected before treatment. * If metastasis is detected at baseline. * Previous participation in any study of investigational drugs within 3 month preceding day 0. * Pregnant women are not allowed to participate in the study.
References
Publications (0)
Data not yet available