Hypofractionated Stereotactic Linear Accelerator Radiotherapy of Uveal Melanoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2009 by Medical University of Vienna
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00872391
First received: March 30, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  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: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Hypofractionated Stereotactic Linear Accelerator Radiotherapy of Malignant Melanoma of the Uvea

Resource links provided by NLM:


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
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

ClinicalTrials.gov processed this record on October 30, 2014