Brief Title
Hypofractionated Stereotactic Linear Accelerator Radiotherapy of Uveal Melanoma
Official Title
Safety and Efficacy of Hypofractionated Stereotactic Linear Accelerator Radiotherapy of Malignant Melanoma of the Uvea
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.
Study Type
Interventional
Primary Outcome
local tumor control (tumor dimensions; secondary complications; visual acuity; survival
Secondary Outcome
histological assessment of the fraction of living cells in eyes requiring secondary enucleation
Condition
Uveal Melanoma
Intervention
Hypofractionated linear accelerator radiotherapy
Study Arms / Comparison Groups
Hypofractionated LINAC radiotherapy
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Radiation
Estimated Enrollment
155
Start Date
March 2009
Primary Completion Date
March 2024
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Martin Zehetmayer, MD, +431 40400, [email protected]
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT00872391
Organization ID
EK 017/2009
Study Sponsor
Medical University of Vienna
Study Sponsor
Martin Zehetmayer, MD, Principal Investigator, Department of Ophthalmology, Medical University of Vienna, Austria
Verification Date
March 2009