RecruitingPhase 2NCT05419076

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

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


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

62 participants

Start Date

Jun 10, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria6

  • 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
  • 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 Criteria5

  • 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
  • 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

Interventions

RADIATIONStereotactic Radiosurgery

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.

PROCEDURECerebrospinal fluid collection

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.


Locations(7)

Memorial Sloan Kettering at Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk - Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau

Rockville Centre, New York, United States

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NCT05419076


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