Hypofractionated Stereotactic Linear Accelerator Radiotherapy of Uveal Melanoma

This study is currently recruiting participants.

Verified by Medical University of Vienna, March 2009

First Received: March 30, 2009 No Changes Posted

Sponsored by:	Medical University of Vienna
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00872391

Purpose

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.

Condition	Intervention
Uveal Melanoma	Radiation: Hypofractionated linear accelerator radiotherapy

Study Type:	Interventional
Study Design:	Treatment, Open Label, Historical Control, Single Group Assignment
Official Title:	Safety and Efficacy of Hypofractionated Stereotactic Linear Accelerator Radiotherapy of Malignant Melanoma of the Uvea

Resource links provided by NLM:

Genetics Home Reference related topics: retinoblastoma

MedlinePlus related topics: Cancer Melanoma Radiation Therapy

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:

local tumor control (tumor dimensions; secondary complications; visual acuity; survival [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

histological assessment of the fraction of living cells in eyes requiring secondary enucleation [ Designated as safety issue: Yes ]

Estimated Enrollment:	155
Study Start Date:	March 2009
Estimated Primary Completion Date:	March 2024 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Hypofractionated LINAC radiotherapy: Experimental	Radiation: Hypofractionated linear accelerator radiotherapy 10 fractions of stereotactic linear accelerator radiotherapy with 6 Gy per fraction at the 80% isodose for the planning target volume.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00872391

Contacts

Contact: Martin Zehetmayer, MD	+431 40400 ext 7941	martin.zehetmayer@meduniwien.ac.at
Contact: Karin Dieckmann, MD	+431 40400 ext 2709	karin.dieckmann@meduniwien.ac.at

Locations

Austria
Department of Ophthalmology and the Department of Radiotherapy and Radiobiology, Medical University of Vienna	Recruiting
Vienna, Austria, 1090
Contact: Martin Zehetmayer, MD +431 40400 ext 7941 martin.zehetmayer@meduniwien.ac.at

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator:

Martin Zehetmayer, MD

Department of Ophthalmology, Medical University of Vienna, Austria

More Information

No publications provided

Responsible Party:	Medical University of Vienna ( Univ. Prof. Dr. Martin Zehetmayer )
Study ID Numbers:	EK 017/2009
Study First Received:	March 30, 2009
Last Updated:	March 30, 2009
ClinicalTrials.gov Identifier:	NCT00872391 History of Changes
Health Authority:	Austria: Ethikkommission

Study placed in the following topic categories:

Neuroectodermal Tumors
Uveal Melanoma
Eye Neoplasms
Eye Diseases
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal

Intraocular Melanoma
Neuroepithelioma
Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Eye Neoplasms
Eye Diseases

Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neuroendocrine Tumors
Melanoma

ClinicalTrials.gov processed this record on September 02, 2009