Hypofractionated Stereotactic Linear Accelerator Radiotherapy of Uveal Melanoma

Uveal Melanoma Clinical Trial

Official title:

Safety and Efficacy of Hypofractionated Stereotactic Linear Accelerator Radiotherapy of Malignant Melanoma of the Uvea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00872391
• Other study ID #: EK 017/2009
• Status: Recruiting
• Phase: N/A
• First received: March 30, 2009
• Last updated: March 30, 2009
• Start date: March 2009

Study information

• Verified date: March 2009
• Source: Medical University of Vienna
• Contact: Martin Zehetmayer, MD
• Phone: +431 40400
• Email: martin.zehetmayer[@]meduniwien.ac.at
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 155
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Uveal Melanoma
• Uveal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Austria	Department of Ophthalmology and the Department of Radiotherapy and Radiobiology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	local tumor control (tumor dimensions; secondary complications; visual acuity; survival			Yes
Secondary	histological assessment of the fraction of living cells in eyes requiring secondary enucleation			Yes