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Stereotactic Radiosurgery for the Treatment of Brain Metastases from Small Cell Lung Cancer
Trial Status: active
This phase II trial tests whether stereotactic radiosurgery (SRS) works to shrink tumors in people with small cell lung cancer that has spread to the brain (brain metastases). SRS is a type of radiation that specifically targets a very small area of the body, such as a particular area of the brain. SRS is a standard treatment for diseases involving the brain and spine, such as cancer that started in another part of the body and has spread to the brain, but it is not usually given to people with brain metastases from small cell lung cancer. People with brain metastasis from small cell lung cancer usually receive radiation therapy to their entire brain first and may receive SRS if new brain metastases appear later. By targeting the part of the brain where the cancer has spread, SRS may shrink the cancer without damaging the healthy parts of the brain. SRS may be more effective than whole brain radiation therapy in treating small cell lung cancer brain metastases.
Inclusion Criteria
Histologic diagnosis of small cell lung cancer
Radiographic diagnosis of up to 10 brain metastases on contrast-enhanced magnetic resonance imaging (MRI)
Age 18 and above
Performance status Karnofsky Performance Status (KPS) 60-100/Eastern Cooperative Oncology Group (ECOG) 0-2
Female patients must be of non-reproductive potential or have a negative serum pregnancy test at the time of enrollment
The patient or legally authorized representative is able to provide informed consent
Exclusion Criteria
Unable to undergo contrast-enhanced MRI brain or spine
Leptomeningeal disease confirmed on lumbar puncture, MRI brain, or MRI spine
Pregnant or lactating women
Prior brain-directed radiotherapy
Uncontrolled systemic disease without reasonable systemic therapy options felt likely to result in death as observed on computed tomography (CT) or positron emission tomography (PET)/CT imaging, no more than 3 months before study enrollment
Additional locations may be listed on ClinicalTrials.gov for NCT05419076.
I. To determine whether 6-month overall survival of patients with small cell lung cancer (SCLC) bone metastases (BM) treated with stereotactic radiosurgery (SRS) is acceptable as compared to the historic control rate of patients treated with whole brain radiotherapy (WBRT).
SECONDARY OBJECTIVES:
I. To assess central nervous system (CNS) progression-free survival (PFS).
II. To assess rate of leptomeningeal progression.
EXPLORATORY OBJECTIVES:
I. To assess local progression, regional progression, and radiation necrosis with SRS.
II. To identify potentially useful biomarkers for CNS failure in blood and cerebrospinal fluid (CSF) collected at study enrollment, 8-12 weeks after SRS, and at CNS disease progression including circulating tumor deoxyribonucleic acid (ctDNA), circulating tumor cells (CTCs), ribonucleic acid (RNA), or proteins.
OUTLINE:
Patients undergo SRS over 45 minutes for 1, 3, or 5 doses (fractions) at the discretion of the treating physician. Patients also undergo magnetic resonance imaging (MRI) during screening and follow-up, cerebrospinal fluid (CSF) and blood sample collection during screening and optionally during follow-up.
After completion of study treatment, patients are followed up at 3 and 6 months, and at the time of disease progression.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationMemorial Sloan Kettering Cancer Center
