Trial Information
Safety and Efficacy of Hypofractionated Stereotactic Linear Accelerator Radiotherapy of Malignant Melanoma of the Uvea
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.
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
local tumor control (tumor dimensions; secondary complications; visual acuity; survival
Safety Issue:
Yes
Principal Investigator
Martin Zehetmayer, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Ophthalmology, Medical University of Vienna, Austria
Authority:
Austria: Ethikkommission
Study ID:
EK 017/2009
NCT ID:
NCT00872391
Start Date:
March 2009
Completion Date:
Related Keywords:
- Uveal Melanoma
- Melanoma
- Uveal Neoplasms