Lung Cancer, Lung Cancer Metastatic, Brain Metastases, Brain Metastases, Adult, Small-cell Lung Cancer, Small Cell Lung Carcinoma
Conditions
Keywords
Stereotactic Radiosurgery, small cell lung cancer, small cell lung carcinoma, lung cancer, lung cancer metastatic, brain metastases, 22-133, Memorial Sloan Kettering Cancer Center
Brief 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.
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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 6 months | 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. |
Countries
United States
Contacts
CONTACTLuke Pike, MD
CONTACTBrandon Imber, MD
PRINCIPAL_INVESTIGATORLuke Pike, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed