Clinical trial · Observational
MELanoma Brain Metastasis Treated With CYberknife
Impact of Stereotactic Radiosurgery With Cyberknife In Patients With Brain Melanoma Metastases In The Era Of New Drugs
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260911-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin Cancer) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Fifty patients receiving radiotherapy as first local approach for melanoma brain metastases
- description
- Patients will receive stereotactic radiotherapy as first local approach for melanoma brain metastases in combination with target therapy and/or immunotherapy. Patients will be followed every three months after the end of radiotherapy in order to collect oncological outcome, side effects and Quality of life data.
Primary outcomes (1)
- measure
- Intracranial in-field progression-free survival (IIFPFS)
- timeFrame
- From the end of radiotherapy through study completion, every three months.
- description
- 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%).
Secondary outcomes (9)
- measure
- Overall survival (OS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 * Written informed consent for treatment and research purposes * Melanoma Brain Metastases (MBM) diagnosed with brain MRI/CT * MBM treatable with stereotactic radiotherapy * Systemic therapy (immunotherapy, target therapy, or both) is allowed, as concurrent or non-concurrent treatment with stereotactic radiotherapy Exclusion Criteria: * 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)
References
Publications (0)
Data not yet available