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Stereotactic Radiosurgery (SRS) for Multiple CNS Mets

Primary Purpose

Metastatic Cancer, Brain Metastases

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stereotactic Radiosurgery
Sponsored by
The Cooper Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Cancer focused on measuring Brain, CNS, Metastases

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MD Anderson Cancer Center at Cooper

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stereotactic Radiosurgery

Arm Description

Outcomes

Primary Outcome Measures

Overall survival
Distant CNS free survival (new lesions in CNS)

Secondary Outcome Measures

Quality of life (as determined by FACT-Br)
Local control (For CNS, local control refers to treated lesions)
Timing and need for salvage therapy (whole brain radiation or repeat whole brain radiation)
Median dose to whole brain with SRS
Neurocognitive testing (Montreal Cognitive Assessment)
Adverse Events for Safety and Tolerability of treatment

Full Information

First Posted
April 3, 2014
Last Updated
December 21, 2021
Sponsor
The Cooper Health System
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1. Study Identification

Unique Protocol Identification Number
NCT02567643
Brief Title
Stereotactic Radiosurgery (SRS) for Multiple CNS Mets
Official Title
Stereotactic Radiosurgery for Multiple (5+) CNS Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Withdrawn
Study Start Date
May 2013 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cooper Health System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer, Brain Metastases
Keywords
Brain, CNS, Metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stereotactic Radiosurgery
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Radiosurgery
Other Intervention Name(s)
Gamma Knife, Cyber Knife, SRS
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
6 months
Title
Distant CNS free survival (new lesions in CNS)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of life (as determined by FACT-Br)
Time Frame
6 months
Title
Local control (For CNS, local control refers to treated lesions)
Time Frame
6 months
Title
Timing and need for salvage therapy (whole brain radiation or repeat whole brain radiation)
Time Frame
6 months
Title
Median dose to whole brain with SRS
Time Frame
6 months
Title
Neurocognitive testing (Montreal Cognitive Assessment)
Time Frame
6 months
Title
Adverse Events for Safety and Tolerability of treatment
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
MD Anderson Cancer Center at Cooper
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States

12. IPD Sharing Statement

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