Observation for Patients With Asymptomatic CNS Metastatic Disease



Status:Completed
Conditions:Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:5/11/2018
Start Date:February 2014
End Date:December 1, 2017

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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.

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

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
We found this trial at
1
site
1 Cooper Plaza
Camden, New Jersey 08103
(856) 342-2000
Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
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mi
from
Camden, NJ
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