Impact of Stereotactic Radiosurgery With Cyberknife In Patients With Brain Melanoma Metastases In The Era Of New Drugs
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Intracranial in-field progression-free survival (IIFPFS)
研究概览
简要总结
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.
详细描述
The therapeutic landscape of metastatic melanoma has undergone a radical transformation in the last decade, largely due to the recent introduction of immune checkpoint inhibitors (IT) and targeted therapies (TTs), and advances in surgery and radiotherapy (RT), which have changed the outlook of patients with melanoma brain metastasis.
Radiation therapy has been and remains an important component of treatment for patients with melanoma brain metastases.
Particularly, stereotactic radiosurgery (SRS), highly precise RT technique, for single or a small number of metastases, has emerged as a crucial component in the management of melanoma brain metastases, with whole brain RT usually reserved for selected patients who have widespread intracranial metastatic disease. SRS relies on the delivery of concentrated, high doses of radiation to one or more metastatic brain lesions of otherwise radio-resistant tumors such as melanoma, providing effective local control (LC) of the disease while minimizing damage to surrounding healthy tissue. SRS can be employed both as an independent primary local therapy, allowing a swifter transition to systemic therapy compared to classic surgical resection and as a salvage procedure after ineffective systemic treatment when the number of MBMs remains below 5-10 and their size is below 3 cm.
A recent systematic review of RT alone for MBMs reported a median survival of 7.5 months (IQR-6.7-9.0-months) after SRS and 3.5 months (IQR-2.4-4.0-months) after whole brain RT.
Although these advances have successfully improved the outcomes of patients with metastatic melanoma, its management remains challenging and complex, requiring a multidisciplinary approach that integrates surgery, systemic therapy, and RT to optimize patient outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
结局指标
主要结局
Intracranial in-field progression-free survival (IIFPFS)
时间窗: From the end of radiotherapy through study completion, every three months.
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%).
次要结局
- 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.)
- Local control (LC)(From the end of radiotherapy through study completion, every three months.)
- Adverse events(From the end of radiotherapy through study completion, every three months.)
- Quality of Life data (QoL) - EORTC QLQ BN20(From the baseline (start of radiotehrapy), to the end of study (12 months), every three months.)
- Quality of Life data (QoL) - EORTC QLQ C30 questionnaires.(From the baseline (start of radiotehrapy), to the end of study (12 months), every three months.)