Uveal MelanomaNCT00872391
Hypofractionated Stereotactic Linear Accelerator Radiotherapy of Uveal Melanoma
A study testing Hypofractionated linear accelerator radiotherapy in people with Uveal Melanoma, run by Medical University of Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveal Melanoma
- What is being tested?
- Hypofractionated linear accelerator radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteAustria
- Study dates
- Mar 2009to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Department of Ophthalmology and the Department of Radiotherapy and Radiobiology, Medical University of Vienna
Vienna, State of Vienna, 1090
Martin Zehetmayer, MD, +431 40400 ext. 7941, martin.zehetmayer@meduniwien.ac.at
About this study
Official title: Safety and Efficacy of Hypofractionated Stereotactic Linear Accelerator Radiotherapy of Malignant Melanoma of the Uvea
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.
- Conditions
- Uveal Melanoma
- Being tested
- Hypofractionated linear accelerator radiotherapy
- Medical subject headings
- Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated linear accelerator radiotherapyRadiation
10 fractions of stereotactic linear accelerator radiotherapy with 6 Gy per fraction at the 80% isodose for the planning target volume.
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated LINAC radiotherapy | Experimental | Not described Receives: Radiation: Hypofractionated linear accelerator radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
local tumor control (tumor dimensions; secondary complications; visual acuity; survival
Secondary outcomes (1)
histological assessment of the fraction of living cells in eyes requiring secondary enucleation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveal MelanomaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Martin Zehetmayer, MD, Principal investigator, Department of Ophthalmology, Medical University of Vienna, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00872391
- Sponsor's protocol ID
- EK 017/2009
- Status last verified
- Mar 2009
- First submitted
- 30 Mar 2009
- Last updated
- 31 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Hypofractionated Stereotactic Linear Accelerator Radiotherapy of Malignant Melanoma of the Uvea
- ClinicalTrials.gov ID
- NCT00872391
- Acronym / sponsor ID
- EK 017/2009
- Conditions
- Uveal Melanoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Mar 2024 (estimated)
- First posted
- 31 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated LINAC radiotherapy | Experimental | Radiation: Hypofractionated linear accelerator radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypofractionated linear accelerator radiotherapy10 fractions of stereotactic linear accelerator radiotherapy with 6 Gy per fraction at the 80% isodose for the planning target volume. | Radiation | Hypofractionated LINAC radiotherapy |
Primary outcome
local tumor control (tumor dimensions; secondary complications; visual acuity; survival
1 secondary outcome
histological assessment of the fraction of living cells in eyes requiring secondary enucleation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Zehetmayer, MD principal investigator
Department of Ophthalmology, Medical University of Vienna, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated linear accelerator radiotherapy in people with Uveal Melanoma, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Zehetmayer, MD (+431 40400 ext. 7941, martin.zehetmayer@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
local tumor control (tumor dimensions; secondary complications; visual acuity; survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2009.