A Study of Stereotactic Radiosurgery (SRS) for People With Lung Cancer That Has Spread to the Brain

Study Overview
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Brief Summary
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The purpose of the study is to see if stereotactic radiosurgery/SRS is an effective treatment for people with a new diagnosis of brain metastases from small cell lung cancer/SCLC.

Official Title
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A Single Arm Phase II Study Assessing Efficacy of Stereotactic Radiosurgery (SRS) for Brain Metastasis (BM) From Small Cell Lung Cancer (SCLC)

Conditions
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Lung Cancer, Lung Cancer Metastatic, Brain Metastases, Brain Metastases, Adult, Small-cell Lung Cancer, Small Cell Lung Carcinoma

Intervention / Treatment
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* Radiation: Stereotactic Radiosurgery
* Procedure: Cerebrospinal fluid collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologic diagnosis of small cell lung cancer Radiographic diagnosis of up to 10 brain metastases on contrast-enhanced MRI Age 18 and above Performance status KPS 60-100/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 CT or PET/CT imaging, no more than 3 months before study enrollment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants with small cell lung cancer with brain metastases<br>Participants may be newly diagnosed small cell lung cancer with brain metastases at initial staging, or can alternatively be patients who develop brain metastases on therapy or during surveillance of systemic disease. | Radiation: Stereotactic Radiosurgery<br>* All participants will undergo MSK standard SRS. A CT simulation will be performed per institutional standards, typically with contrast unless a contraindication exists. A contrast-enhanced MRI with 1mm slices will be fused to the CT simulation scan for the purposes of SRS planning. The SRS GTV will be considered the visible tumor on MRI and CT contrast enhanced studies. An expansion of 1-2mm will be used to create the PTV. Radiation dose may be between 16Gy and 30Gy in 1 to 5 fractions, per the discretion of the treating radiation oncologist. Participants with multiple lesions may receive different doses to each lesion per the discretion of the treating radiation oncologist. Concurrent treatment to other body sites is permitted.<br>* Other names: SRS;Procedure: Cerebrospinal fluid collection<br>* All participants will undergo lumbar puncture for CSF collection at study enrollment.. Lumbar punctures will be performed by clinical staff in neurology or neuroradiology, per the discretion of the treating radiation oncologist, as dictated by scheduling limitations and expected clinical difficulty in obtaining a sample (e.g. requiring fluoroscopic guidance), with input from the PI, neurology, and/or neuroradiology as necessary. Participants will be encouraged to undergo repeat lumbar puncture for CSF collection at 3 months (+/- 4 weeks), and at the time of CNS disease progression, though these latter timepoints are not required. CSF cytology will be evaluated.<br>* Other names: CSF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | The primary endpoint of this study is the rate of overall survival at 6 months, with time measured from the start of SRS treatment. Participants will be censored at the date of last follow up or the last date the participant was known to be alive. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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22-133, Stereotactic Radiosurgery, small cell lung cancer, small cell lung carcinoma, lung cancer, lung cancer metastatic, brain metastases, Memorial Sloan Kettering Cancer Center