Hypofractionated Stereotactic Linear Accelerator Radiotherapy of Uveal Melanoma

NCT ID: NCT00872391

Last Updated: 2009-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Uveal Melanoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hypofractionated LINAC radiotherapy

Group Type EXPERIMENTAL

Hypofractionated linear accelerator radiotherapy

Intervention Type RADIATION

10 fractions of stereotactic linear accelerator radiotherapy with 6 Gy per fraction at the 80% isodose for the planning target volume.

Interventions

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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.

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Medical University of Vienna

Principal Investigators

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Martin Zehetmayer, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology, Medical University of Vienna, Austria

Locations

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Department of Ophthalmology and the Department of Radiotherapy and Radiobiology, Medical University of Vienna

Vienna, Vienna, Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Martin Zehetmayer, MD

Role: CONTACT

Phone: +431 40400

Email: [email protected]

Karin Dieckmann, MD

Role: CONTACT

Phone: +431 40400

Email: [email protected]

Facility Contacts

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Martin Zehetmayer, MD

Role: primary

Other Identifiers

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EK 017/2009

Identifier Type: -

Identifier Source: org_study_id