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Hypofractionated Stereotactic Linear Accelerator Radiotherapy of Uveal Melanoma

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Medical University of Vienna

Status

Unknown

Conditions

Uveal Melanoma

Treatments

Radiation: Hypofractionated linear accelerator radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00872391
EK 017/2009

Details and patient eligibility

About

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.

Enrollment

155 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

155 participants in 1 patient group

Hypofractionated LINAC radiotherapy
Experimental group
Treatment:
Radiation: Hypofractionated linear accelerator radiotherapy

Trial contacts and locations

1

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Central trial contact

Karin Dieckmann, MD; Martin Zehetmayer, MD

Data sourced from clinicaltrials.gov

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