Recruiting NCT05419076
A Study of Stereotactic Radiosurgery (SRS) for People With Lung Cancer That Has Spread to the Brain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stereotactic Radiosurgery, Cerebrospinal fluid collection.
- Who it may be relevant to
- Registry conditions: Lung Cancer, Lung Cancer Metastatic, Brain Metastases, Brain Metastases, Adult. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Single Arm Phase II Study Assessing Efficacy of Stereotactic Radiosurgery (SRS) for Brain Metastasis (BM) From Small Cell Lung Cancer (SCLC)
Overview
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
- 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 - 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 f
Primary outcome measures
- Overall survival [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 7 centers
- Memorial Sloan Kettering at Basking Ridge — Basking Ridge
- Memorial Sloan Kettering Monmouth — Middletown
- Memorial Sloan Kettering Bergen — Montvale
- Memorial Sloan Kettering Suffolk - Commack — Commack
- Memorial Sloan Kettering Westchester — Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
- Memorial Sloan Kettering Nassau — Rockville Centre
Identifiers
NCT: NCT05419076 · 22-133