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Hypofractionated Stereotactic Linear Accelerator Radiotherapy of Uveal Melanoma

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ClinicalTrials.gov Identifier: NCT00872391
Recruitment Status : Recruiting
First Posted : March 31, 2009
Last Update Posted : March 31, 2009
Sponsor:
Information provided by:
Medical University of Vienna

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.

Condition or disease Intervention/treatment
Uveal Melanoma Radiation: Hypofractionated linear accelerator radiotherapy

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 155 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Hypofractionated Stereotactic Linear Accelerator Radiotherapy of Malignant Melanoma of the Uvea
Study Start Date : March 2009
Estimated Primary Completion Date : March 2024


Arm Intervention/treatment
Experimental: Hypofractionated LINAC radiotherapy 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.



Primary Outcome Measures :
  1. local tumor control (tumor dimensions; secondary complications; visual acuity; survival

Secondary Outcome Measures :
  1. histological assessment of the fraction of living cells in eyes requiring secondary enucleation


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Univ. Prof. Dr. Martin Zehetmayer, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00872391     History of Changes
Other Study ID Numbers: EK 017/2009
First Posted: March 31, 2009    Key Record Dates
Last Update Posted: March 31, 2009
Last Verified: March 2009

Additional relevant MeSH terms:
Melanoma
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases