Uveal Melanoma
Conditions
Brief summary
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.
Interventions
RADIATIONHypofractionated linear accelerator radiotherapy
10 fractions of stereotactic linear accelerator radiotherapy with 6 Gy per fraction at the 80% isodose for the planning target volume.
Sponsors
Medical University of Vienna
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| local tumor control (tumor dimensions; secondary complications; visual acuity; survival | — |
Secondary
| Measure | Time frame |
|---|---|
| histological assessment of the fraction of living cells in eyes requiring secondary enucleation | — |
Countries
Austria
Contacts
Primary ContactMartin Zehetmayer, MD
Backup ContactKarin Dieckmann, MD
Outcome results
None listed