Actively Recruiting
A Single Arm Phase II Study Assessing Efficacy of Stereotactic Radiosurgery (SRS) for Brain Metastases from Small Cell Lung Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-11
62
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating stereotactic radiosurgery (SRS) as a treatment for people newly diagnosed with brain metastases originating from small cell lung cancer (SCLC). This single-arm Phase II study aims to assess whether SRS is effective in improving overall survival at 6 months for these patients. Participants may be newly diagnosed at initial staging or develop brain metastases during therapy or surveillance. All participants will receive Memorial Sloan Kettering's standard SRS treatment, which includes a CT simulation and contrast-enhanced MRI scans for precise planning. Radiation doses range from 16Gy to 30Gy delivered in 1 to 5 sessions, tailored by the treating radiation oncologist. Some participants may receive different doses for multiple brain lesions. Concurrent treatments to other body sites are allowed. Additionally, cerebrospinal fluid (CSF) will be collected via lumbar puncture at enrollment and optionally at 3 months and disease progression to assess CSF cytology. During the study, participants will undergo imaging scans and clinical assessments to monitor brain metastases and overall health status. Lumbar punctures will be performed by clinical staff to collect CSF samples. The main outcome measured is overall survival at 6 months. The study began in June 2022 and will continue through June 2026. Participants must provide informed consent and will be closely monitored throughout their involvement.
CONDITIONS
Brief Title
A Study of Stereotactic Radiosurgery (SRS) for People With Lung Cancer That Has Spread to the Brain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 or ECOG 0-2
- Female patients must be of non-reproductive potential or have a negative serum pregnancy test at enrollment
- Ability to provide informed consent by patient or legally authorized representative
You will not qualify if you...
- Unable to undergo contrast-enhanced MRI of the brain
- Presence of leptomeningeal disease confirmed by lumbar puncture or MRI of brain or spine
- Pregnant or lactating women
- Prior brain-directed radiotherapy
- Uncontrolled systemic disease without reasonable therapy options likely to result in death within 3 months before enrollment
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Typically 1 to 5 fractions over days to weeks
Participants receive stereotactic radiosurgery (SRS) targeting brain metastases. Radiation dose and number of fractions vary per individual treatment plans. Lumbar puncture for cerebrospinal fluid (CSF) collection is performed at enrollment.
1 treatment period with SRS sessions and 1 lumbar puncture at enrollment
Duration - Up to 6 months or longer depending on disease progression
Participants are encouraged to undergo repeat lumbar puncture for CSF collection at around 3 months and at the time of central nervous system disease progression, though these follow-ups are optional.
Additional visits for lumbar puncture at 3 months (+/- 4 weeks) and as needed for disease progression
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk - Commack
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau
Rockville Centre, New York, United States, 11553
Actively Recruiting
Research Team
L
Luke Pike, MD
B
Brandon Imber, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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