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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05419076
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Memorial Sloan Kettering Cancer Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Luke Pike, MD
Principal Investigator Affiliation	Memorial Sloan Kettering Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Lung Cancer, Lung Cancer Metastatic, Brain Metastases, Brain Metastases, Adult, Small-cell Lung Cancer, Small Cell Lung Carcinoma
Study Website:	View Trial Website

Arms & Interventions

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.

Interventions

Radiation: - Stereotactic 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.

Procedure: - Cerebrospinal 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Basking Ridge, New Jersey

Status

Recruiting

Address

Memorial Sloan Kettering at Basking Ridge

Basking Ridge, New Jersey, 07920

Site Contact

Luke Pike, MD

[email protected]

201-775-7604

Memorial Sloan Kettering Monmouth, Middletown, New Jersey

Status