Hypofractionated Stereotactic Linear Accelerator Radiotherapy of Uveal Melanoma
This study is currently recruiting participants.
Verified March 2009 by Medical University of Vienna
Sponsor:
Medical University of Vienna
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
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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
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 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 |
ClinicalTrials.gov processed this record on May 21, 2013