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

Lung Cancer Clinical Trial

Official title:

A Single Arm Phase II Study Assessing Efficacy of Stereotactic Radiosurgery (SRS) for Brain Metastasis (BM) From Small Cell Lung Cancer (SCLC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05419076
• Other study ID #: 22-133
• Status: Recruiting
• Phase: Phase 2
• Start date: June 10, 2022
• Est. completion date: June 10, 2025

Study information

• Verified date: June 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Luke Pike, MD
• Phone: 201-775-7604
• Email: PikeL[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: June 10, 2025
• Est. primary completion date: June 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Metastases
• Brain Metastases, Adult
• Brain Neoplasms
• Lung Cancer
• Lung Cancer Metastatic
• Lung Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary
• Small Cell Lung Carcinoma
• Small-cell Lung Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering at Basking Ridge	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Suffolk - Commack	Commack	New York
United States	Memorial Sloan Kettering Westchester	Harrison	New York
United States	Memorial Sloan Kettering Monmouth	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York
United States	Memorial Sloan Kettering Nassau	Rockville Centre	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	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.	6 months

External Links

•   Memorial Sloan Kettering Cancer Center