Hypofractionated Stereotactic Linear Accelerator Radiotherapy of Uveal Melanoma

Not Applicable

• Conditions: Uveal Melanoma
• Interventions: Radiation: Hypofractionated linear accelerator radiotherapy

• Registration Number: NCT00872391
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-03
• Study Start: 2009-03
• Study First Submitted: 2009-03-30
• Study First Submitted QC: 2009-03-30
• Last Update Submitted: 2009-03-30
• Study First Posted: 2009-03-31
• Last Update Posted: 2009-03-31
• Primary Completion: 2024-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 155

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hypofractionated LINAC radiotherapy	Hypofractionated linear accelerator radiotherapy	-

Primary Outcome Measures

Name	Time	Method
local tumor control (tumor dimensions; secondary complications; visual acuity; survival

Secondary Outcome Measures

Name	Time	Method
histological assessment of the fraction of living cells in eyes requiring secondary enucleation

Trial Locations

Locations (1)

Department of Ophthalmology and the Department of Radiotherapy and Radiobiology, Medical University of Vienna; 🇦🇹 Vienna, Austria