Hypofractionated Stereotactic Linear Accelerator Radiotherapy of Uveal Melanoma
Safety and Efficacy of Hypofractionated Stereotactic Linear Accelerator Radiotherapy of Malignant Melanoma of the Uvea
1 other identifier
interventional
155
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 30, 2009
CompletedFirst Posted
Study publicly available on registry
March 31, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedMarch 31, 2009
March 1, 2009
15 years
March 30, 2009
March 30, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
local tumor control (tumor dimensions; secondary complications; visual acuity; survival
Secondary Outcomes (1)
histological assessment of the fraction of living cells in eyes requiring secondary enucleation
Study Arms (1)
Hypofractionated LINAC radiotherapy
EXPERIMENTALInterventions
10 fractions of stereotactic linear accelerator radiotherapy with 6 Gy per fraction at the 80% isodose for the planning target volume.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Ophthalmology and the Department of Radiotherapy and Radiobiology, Medical University of Vienna
Vienna, Vienna, 1090, Austria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Zehetmayer, MD
Department of Ophthalmology, Medical University of Vienna, Austria
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 30, 2009
First Posted
March 31, 2009
Study Start
March 1, 2009
Primary Completion
March 1, 2024
Last Updated
March 31, 2009
Record last verified: 2009-03