Stereotactic Radiosurgery (SRS) for Multiple CNS Mets

December 21, 2021 updated by: The Cooper Health System

Stereotactic Radiosurgery for Multiple (5+) CNS Metastases

This study is designed to determine outcome for patients with 5 or more central nervous system (CNS) metastatic lesions treated with stereotactic radiosurgery (SRS).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Locations

  • United States
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • MD Anderson Cancer Center at Cooper

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • CNS metastatic disease with 5 to 25 CNS mets that require treatment (note that previous SRS, WBRT, and resection for previous CNS mets is allowed. At time of protocol treatment, patient must have 5 or more new or progressing CNS mets that require treatment, this includes new lesions not before seen or progression of previous lesions.). While definition of new lesions is fairly straightforward, the definition of progression of old lesion is at the discretion of the treating team but it is recommended that progression be defined by a multidisciplinary team (radiation oncologist, neurosurgeon, neuro-radiologist). Note that treatment of tumor bed does not count as treatment of an active lesion.

For example,

  • Patient with 10 lesions in 2010 who had whole brain radiation and now has 2 new lesions and progression of 3 previously noted lesions would be eligible
  • Patient with 31 lesions in 2010 who had whole brain radiation and now has 26 stable lesions and progression of 5 lesions is eligible. Although the patient has more than 25 lesions the majority are stable and do not require treatment.
  • Patient with 6 brain lesions has surgical resection of one lesion is eligible. Patient will require treatment for 5 lesions. Patient can also have treatment of surgical tumor bed but this does not count towards 5 lesions required for eligibility.
  • All lesions < 4 cm in greatest dimension
  • Able to have an MRI with contrast
  • MRI within 6 weeks (MRI for eligibility can be done without contrast but planning MRI for radiosurgery will have contrast).
  • Patients of child-bearing age must agree to contraception until radiosurgery has been completed.
  • Patients able to undergo radiosurgery. Gamma knife radiosurgery is preferred for this protocol but cyberknife can also be used at the discretion of treating physicians.
  • Karnofsky Performance Scale (KPS) 50 or better

  • Eligible primaries:

    • Lung (NSCLC)
    • Lung (SCLC) that have had previous whole brain radiation
    • GI
    • Head and Neck
    • Gyn
    • Prostate
    • Breast
    • Kidney
    • Melanoma
    • Sarcoma

Exclusion Criteria:

  • Less than 5 CNS lesions (can have had previously treated lesions by either surgery or SRS, but at time of protocol SRS must have 5 or more untreated lesions).
  • More than 25 CNS lesions that require treatment (note that the patient can have had previous metastatic lesions, but at the time of enrollment cannot have more than 25 new lesions).

For example:

Patient with 12 brain lesions has whole brain radiation in 2010, on follow-up has progression of 3 lesions is not eligible since less than 5 lesions require treatment.

Patient with 5 brain lesions has surgical resection of one lesions, patient is not eligible since has less than 5 lesions that require treatment.

  • Ineligible primaries Lymphoma Lung (SCLC) that have not had previous whole brain radiation Primary CNS tumors Leptomeningeal disease in CNS
  • Must not have any chemotherapy or targeted therapy within 24 hours prior to SRS
  • Patients unable to have an MRI (secondary for example to metal hardware)
  • Patients unable to have MRI contrast (secondary for example to poor renal function).
  • CNS lesion > 4 cm in any dimension
  • KPS 40 or less
  • Serious or other life threatening illness as determined by the treating physician

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Stereotactic Radiosurgery
Radiation: Stereotactic Radiosurgery
Other Names:
  • Gamma Knife
  • SRS
  • Cyber Knife

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Overall survival
Time Frame: 6 months
6 months
Distant CNS free survival (new lesions in CNS)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Quality of life (as determined by FACT-Br)
Time Frame: 6 months
6 months
Local control (For CNS, local control refers to treated lesions)
Time Frame: 6 months
6 months
Timing and need for salvage therapy (whole brain radiation or repeat whole brain radiation)
Time Frame: 6 months
6 months
Median dose to whole brain with SRS
Time Frame: 6 months
6 months
Neurocognitive testing (Montreal Cognitive Assessment)
Time Frame: 6 months
6 months
Adverse Events for Safety and Tolerability of treatment
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Cooper Health System

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 13-032

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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