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

June 9, 2023 updated by: Memorial Sloan Kettering Cancer Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

62

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering at Basking Ridge
        • Contact:
          • Luke Pike, MD
          • Phone Number: 201-775-7604
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth
        • Contact:
          • Luke Pike, MD
          • Phone Number: 201-775-7604
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen
        • Contact:
          • Luke Pike, MD
          • Phone Number: 201-775-7604
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Suffolk - Commack
        • Contact:
          • Luke Pike, MD
          • Phone Number: 201-775-7604
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester
        • Contact:
          • Luke Pike, MD
          • Phone Number: 201-775-7604
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
        • Contact:
          • Luke Pike, MD
          • Phone Number: 201-775-7604
      • Rockville Centre, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau
        • Contact:
          • Luke Pike, MD
          • Phone Number: 201-775-7604

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Other Names:
  • SRS
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.
Other Names:
  • CSF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Luke Pike, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2022

Primary Completion (Estimated)

June 10, 2025

Study Completion (Estimated)

June 10, 2025

Study Registration Dates

First Submitted

June 10, 2022

First Submitted That Met QC Criteria

June 10, 2022

First Posted (Actual)

June 15, 2022

Study Record Updates

Last Update Posted (Actual)

June 12, 2023

Last Update Submitted That Met QC Criteria

June 9, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-133

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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