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 — RADIATIONAll 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 — PROCEDUREAll 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 metastasesParticipants 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
- Luke Pike, MD201-775-7604
- Brandon Imber, MD631-212-6346
Locations (7)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Memorial Sloan Kettering at Basking Ridge | Basking Ridge | New Jersey | 07920 | Luke Pike, MD 201-775-7604 |
| Memorial Sloan Kettering Monmouth | Middletown | New Jersey | 07748 | Luke Pike, MD 201-775-7604 |
| Memorial Sloan Kettering Bergen | Montvale | New Jersey | 07645 | Luke Pike, MD 201-775-7604 |
| Memorial Sloan Kettering Suffolk - Commack | Commack | New York | 11725 | Luke Pike, MD 201-775-7604 |
| Memorial Sloan Kettering Westchester | Harrison | New York | 10604 | Luke Pike, MD 201-775-7604 |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | New York | New York | 10065 | Luke Pike, MD 201-775-7604 |
| Memorial Sloan Kettering Nassau | Rockville Centre | New York | 11553 | Luke Pike, MD 201-775-7604 |
Find similar trials in Basking Ridge, NJ
By condition
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By research site
Memorial Sloan Kettering at Basking Ridge· Basking Ridge, NJMemorial Sloan Kettering Monmouth· Middletown, NJMemorial Sloan Kettering Bergen· Montvale, NJMemorial Sloan Kettering Suffolk - Commack· Commack, NYMemorial Sloan Kettering Westchester· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY
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