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Safety and Efficacy of Hypofractionated Stereotactic Linear Accelerator Radiotherapy of Malignant Melanoma of the Uvea


N/A
18 Years
N/A
Open (Enrolling)
Both
Uveal Melanoma

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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

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