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

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT05419076
Phase
PHASE2
Status
Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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
    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.

Study Details

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.

Key Dates

Start date
Jun 10, 2022
Status verified
Jun 2026
Primary completion
Jun 10, 2027
Completion
Jun 10, 2027

Study Design

Enrollment
62 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Participants with small cell lung cancer with brain metastases
    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.

Primary Outcome Measure

Overall survival [ Time Frame: 6 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering at Basking RidgeBasking RidgeNew Jersey07920
Luke Pike, MD
201-775-7604
Memorial Sloan Kettering MonmouthMiddletownNew Jersey07748
Luke Pike, MD
201-775-7604
Memorial Sloan Kettering BergenMontvaleNew Jersey07645
Luke Pike, MD
201-775-7604
Memorial Sloan Kettering Suffolk - CommackCommackNew York11725
Luke Pike, MD
201-775-7604
Memorial Sloan Kettering WestchesterHarrisonNew York10604
Luke Pike, MD
201-775-7604
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Luke Pike, MD
201-775-7604
Memorial Sloan Kettering NassauRockville CentreNew York11553
Luke Pike, MD
201-775-7604

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