MELanoma Brain Metastasis Treated With CYberknife

NCT07691255 | Not Yet Recruiting

• 2 other identifiers: UID 4996L2-594
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Melanoma (Skin Cancer)

Keywords

Stereotactic radiotherapy; Brain metastases

Outcome Measures

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%).

  From the end of radiotherapy through study completion, every three months.

Secondary Outcomes (9)

• Overall survival (OS)

  From the end of radiotherapy through study completion, every three months.

• Progression-free survival (PFS)

  From the end of radiotherapy through study completion, every three months.

• Intracranial out-field progression free survival (IOFPFS)

  From the end of radiotherapy through study completion, every three months.

• Overall intracranial progression free survival (OIPFS)

  From the end of radiotherapy through study completion, every three months.

• Extracranial progression free survival (EPFS)

  From the end of radiotherapy through study completion, every three months.

Study Arms (1)

Fifty patients receiving radiotherapy as first local approach for melanoma brain metastases

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Accuray Incorporated: collaborator
• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology, Milan

Milan, Mi, 20141, Italy

Location

MeSH Terms

Conditions

Melanoma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Samantha Dicuonzo, MD

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samantha Dicuonzo, MD

CONTACT

+39 0257489037; samantha.dicuonzo@ieo.it

Lorenzo Colombi, MD

CONTACT

+39 0257489037; lorenzo.colombi@ieo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: July 8, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: July 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)