MELanoma Brain Metastasis Treated With CYberknife
ConditionMelanoma (Skin Cancer)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEuropean Institute of Oncology
About this trial
Melanoma is a type of cancer that can spread to the brain, making the disease harder to treat and worsening both survival and quality of life.
In recent years, treatments have improved significantly thanks to advances in surgery, radiotherapy, immunotherapy, and targeted therapy. These new treatments have greatly increased survival rates for patients with metastatic melanoma.
This study focuses on stereotactic radiosurgery, a highly precise form of radiotherapy used to treat brain metastases. Researchers want to better understand how this treatment works when combined with immunotherapy or targeted therapy, and whether the timing and sequence of treatments can improve outcomes.
Between 2026 and 2028, patients treated at the IEO for melanoma brain metastases will be observed and their clinical data collected. The goal is to improve future treatment strategies and help doctors choose the best therapeutic approach for each patient.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 18
Written informed consent for treatment and research purposes
Melanoma Brain Metastases (MBM) diagnosed with brain MRI/CT
MBM treatable with stereotactic radiotherapy
Disqualifiers
Leptomeningeal neoplastic infiltration
Previous whole-brain radiotherapy or surgical removal of brain metastases
Patients with histological diagnosis of non-cutaneous melanoma (e.g. uveal melanoma)
Trial population
Patients receiving stereotactic radiotherapy for melanoma brain metastases as first local approach. Target therapy and immunotherapy in combination or not will be permitted. Given the descriptive nature of the study, no formal sample size calculation was performed. The planned sample size was predefined according to historical data from the RT Division and reflects the expected number of eligible patients treated at our institution over the planned three-year study period. Based on these data, we anticipate enrolling approximately 50 patients.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
50 Participants
are grouped into 1 trial groupGroup A: Fifty patients receiving radiotherapy as first local approach for melanoma brain metastases
Trial outcomes
Primary outcomes
1
Intracranial in-field progression-free survival (IIFPFS)
The primary objective of the study is to estimate the 1-year intracranial in-field progression-free survival (IIFPFS). Based on results from a retrospective analysis conducted on patients treated at our institution, we expect a 1-year IIFPFS of approximately 57%. With a sample size of 50 patients, the 95% confidence interval (CI) for the 1-year IIFPFS is expected to have an approximate width of 27% (i.e. 43.5-70.5%).
Time frame
From the end of radiotherapy through study completion, every three months.Secondary outcomes
1
Overall survival (OS)
Defined as the time from the end of radiotherapy to death
Time frame
From the end of radiotherapy through study completion, every three months.2
Progression-free survival (PFS)
Defined as the time from the end of radiotherapy to disease progression (either global intracranial or extracranial) or death, whichever occurred first.
Time frame
From the end of radiotherapy through study completion, every three months.3
Intracranial out-field progression free survival (IOFPFS)
defined as the time from the end of radiotherapy to intracranial out-field progression
Time frame
From the end of radiotherapy through study completion, every three months.4
Overall intracranial progression free survival (OIPFS)
defined as the time from the end of radiotherapy to the global intracranial progression
Time frame
From the end of radiotherapy through study completion, every three months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
European Institute of Oncology
Lead sponsor
Accuray Incorporated
Collaborator
Source ClinicalTrials.gov