Back to resultsHypofractionated Stereotactic Linear Accelerator Radiotherapy of Uveal Melanoma
Primary Purpose
Uveal Melanoma
Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Hypofractionated linear accelerator radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Uveal Melanoma
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.
Sites / Locations
- Department of Ophthalmology and the Department of Radiotherapy and Radiobiology, Medical University of ViennaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hypofractionated LINAC radiotherapy
Arm Description
Outcomes
Primary Outcome Measures
local tumor control (tumor dimensions; secondary complications; visual acuity; survival
Secondary Outcome Measures
histological assessment of the fraction of living cells in eyes requiring secondary enucleation
Full Information
NCT ID
NCT00872391
First Posted
March 30, 2009
Last Updated
March 30, 2009
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT00872391
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Recruiting
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Medical University of Vienna
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveal Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
155 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hypofractionated LINAC radiotherapy
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated linear accelerator radiotherapy
Intervention Description
10 fractions of stereotactic linear accelerator radiotherapy with 6 Gy per fraction at the 80% isodose for the planning target volume.
Primary Outcome Measure Information:
Title
local tumor control (tumor dimensions; secondary complications; visual acuity; survival
Secondary Outcome Measure Information:
Title
histological assessment of the fraction of living cells in eyes requiring secondary enucleation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Zehetmayer, MD
Phone
+431 40400
Ext
7941
Email
martin.zehetmayer@meduniwien.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Karin Dieckmann, MD
Phone
+431 40400
Ext
2709
Email
karin.dieckmann@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Zehetmayer, MD
Organizational Affiliation
Department of Ophthalmology, Medical University of Vienna, Austria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology and the Department of Radiotherapy and Radiobiology, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Zehetmayer, MD
Phone
+431 40400
Ext
7941
Email
martin.zehetmayer@meduniwien.ac.at
12. IPD Sharing Statement
Learn more about this trial
Hypofractionated Stereotactic Linear Accelerator Radiotherapy of Uveal Melanoma
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