Observation for Patients With Asymptomatic CNS Metastatic Disease
Primary Purpose
Cancer, Metastatic Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Observation
Sponsored by
About this trial
This is an interventional treatment trial for Cancer focused on measuring Brain Metastases
Eligibility Criteria
Inclusion Criteria:
- CNS metastatic disease that meets the following:
- No lesion greater than 0.8 cm for patients not on targeted therapy with CNS penetration
- No lesion greater than 1.5 cm for patients on targeted therapy with CNS penetration.
- No previous treatment for the observed lesion. Patients may have had other lesions that have been treated as long as there is at least one index lesion that has not been treated. For example, patient may have had 3 lesions treated in March 2012 with radiosurgery and on recent scan is found to have a new 0.5 cm lesion, this patient is eligible.
- Less than 5 untreated CNS lesions.
- Able to have MRI scan with contrast
- All CNS lesions are asymptomatic. Patient may have symptoms from previous treatment or cancer outside the CNS but cannot have symptoms attributable to the current CNS metastatic disease. This is left to the discretion of the treating physician and in some instances is not easy as sometimes CNS metastatic disease is incidental finding to un-related symptoms.
- 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:
- CNS lesion that does not meet following:
- No lesion greater than 0.8 cm for patients not on targeted therapy with CNS penetration
- No lesion greater than 1.5 cm for patients on targeted therapy with CNS penetration.
- More than 5 CNS lesions (can have had previously treated lesions by either surgery or radiation, but at time of protocol SRS must have 5 or less untreated lesions).
- Symptomatic CNS lesions
- Ineligible primaries
- Lymphoma
- Primary CNS tumors
- SCLC that has not had previous whole brain radiation
- Leptomeningeal disease in CNS
- 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 >0.8 cm in any dimension for patients not on targeted therapy with CNS penetration or >1.5 cm for patients on targeted therapy with CNS penetration.
- Note that there is no KPS cut-off for eligibility
Sites / Locations
- Cooper University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Observation
Arm Description
Patients that meet all inclusion and exclusion criteria are monitored every 2 months for two years or until a therapeutic intervention is warranted.
Outcomes
Primary Outcome Measures
Overall survival
Kaplan-Meier survival analyses
CNS treatment-free survival rate
overall survival combined with CNS treatment
Secondary Outcome Measures
Quality of life
determined by FACT-Br
Natural History of untreated CNS met
Measure the size of CNS target lesion over time
Type of treatment
When/if needed
Indication for treatment
when/if treatment is needed due to discontinuation of observation. Classified between: increase in size to >1cm; interval growth of 0.4 cm in 6-8 weeks; development of edema or increase in edema; development of symptoms; or patient preference.
Neurocognitive testing
Montreal Cognitive Assessment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02866981
Brief Title
Observation for Patients With Asymptomatic CNS Metastatic Disease
Official Title
Observation for Patients With Asymptomatic CNS Metastatic Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
December 1, 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
The purpose of this registry is to determine if select patients with CNS metastatic disease can be safely observed rather than treated. The investigators hypothesize that there is a subset of patients with small asymptomatic CNS mets that do not require treatment, these patients can simply be observed and will not have CNS progression.
Detailed Description
Subjects will be given a consultation with physician investigators in the department of one of the study investigators, who will introduce the study if the subject is potentially eligible.
Information collected at initial assessment:
Quality of life survey (FACT-Br)
History and Physical exam (to include KPS, disease status on most recent non-CNS imaging, chemotherapy history, age).
Measurement of walking pace: patient will walk a pre- measured 6 meters, patient is to be instructed to walk at a normal pace. The time required to travel this distance will be recorded. For patients that are wheelchair bound or otherwise immobile, the pace will be recorded as '0'.
Neurocognitive testing (Montreal Cognitive Assessment)
MRI scan with contrast (must be within 6 weeks)
Observation and Follow-up Visits:
Patients will be seen at 6 weeks and then every 2 months for follow-up (with physical exam) with repeat MRI with contrast at that time
FACT-Br survey to be filled out at each follow-up
Neurocognitive status (Montreal Cognitive Assessment)
Treatment for Progression:
Progression is defined as: Increase in size to > 1 cm (> 2.0 for patients being treated with targeted therapy); Interval growth of 0.4 cm in 6-8 weeks; Development of edema or increase in edema; Development of symptoms from CNS lesion; Patient preference
Patients that meet criteria for treatment will be treated at discretion of treating physician; options can include whole brain radiation, radiosurgery, surgery.
The study does not provide financial or other compensation to subjects
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Metastatic Cancer
Keywords
Brain Metastases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Observation
Arm Type
Experimental
Arm Description
Patients that meet all inclusion and exclusion criteria are monitored every 2 months for two years or until a therapeutic intervention is warranted.
Intervention Type
Other
Intervention Name(s)
Observation
Primary Outcome Measure Information:
Title
Overall survival
Description
Kaplan-Meier survival analyses
Time Frame
Every two months for two years
Title
CNS treatment-free survival rate
Description
overall survival combined with CNS treatment
Time Frame
Every two months for two years
Secondary Outcome Measure Information:
Title
Quality of life
Description
determined by FACT-Br
Time Frame
Every two months for two years
Title
Natural History of untreated CNS met
Description
Measure the size of CNS target lesion over time
Time Frame
Every two months for two years
Title
Type of treatment
Description
When/if needed
Time Frame
Every two months for two years
Title
Indication for treatment
Description
when/if treatment is needed due to discontinuation of observation. Classified between: increase in size to >1cm; interval growth of 0.4 cm in 6-8 weeks; development of edema or increase in edema; development of symptoms; or patient preference.
Time Frame
Every two months for two years
Title
Neurocognitive testing
Description
Montreal Cognitive Assessment
Time Frame
Every two months for two years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
CNS metastatic disease that meets the following:
No lesion greater than 0.8 cm for patients not on targeted therapy with CNS penetration
No lesion greater than 1.5 cm for patients on targeted therapy with CNS penetration.
No previous treatment for the observed lesion. Patients may have had other lesions that have been treated as long as there is at least one index lesion that has not been treated. For example, patient may have had 3 lesions treated in March 2012 with radiosurgery and on recent scan is found to have a new 0.5 cm lesion, this patient is eligible.
Less than 5 untreated CNS lesions.
Able to have MRI scan with contrast
All CNS lesions are asymptomatic. Patient may have symptoms from previous treatment or cancer outside the CNS but cannot have symptoms attributable to the current CNS metastatic disease. This is left to the discretion of the treating physician and in some instances is not easy as sometimes CNS metastatic disease is incidental finding to un-related symptoms.
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:
CNS lesion that does not meet following:
No lesion greater than 0.8 cm for patients not on targeted therapy with CNS penetration
No lesion greater than 1.5 cm for patients on targeted therapy with CNS penetration.
More than 5 CNS lesions (can have had previously treated lesions by either surgery or radiation, but at time of protocol SRS must have 5 or less untreated lesions).
Symptomatic CNS lesions
Ineligible primaries
Lymphoma
Primary CNS tumors
SCLC that has not had previous whole brain radiation
Leptomeningeal disease in CNS
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 >0.8 cm in any dimension for patients not on targeted therapy with CNS penetration or >1.5 cm for patients on targeted therapy with CNS penetration.
Note that there is no KPS cut-off for eligibility
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harry Mazurek, MD
Organizational Affiliation
Cooper University Health System
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gregory Kubicek, MD
Organizational Affiliation
Cooper University Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Observation for Patients With Asymptomatic CNS Metastatic Disease
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