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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologic diagnosis of small cell lung cancer

Radiographic diagnosis of up to 20 brain metastases on contrast-enhanced MRI

Age 18 and above

Performance status KPS 60-100/ECOG 0-2

Disqualifiers

Unable to undergo contrast-enhanced MRI brain

Leptomeningeal disease confirmed on lumbar puncture, MRI brain, or MRI spine

Pregnant or lactating women

Prior brain-directed radiotherapy

Trial design

Design model

Single group

Treatments tested in this trial

  • Stereotactic Radiosurgery

    Radiation

    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.

  • Cerebrospinal fluid collection

    Procedure/Surgery

    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.

Treatment groups

62 Participants
are divided into 1 treatment group
Group A: Participants with small cell lung cancer with brain metastasesExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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