Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02866981 : Observation for Patients With Asymptomatic CNS Metastatic Disease
PhasePhase 2
AgesMin: N/A Max: N/A
Eligibility
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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02866981      |      Link to official Clinicaltrials.gov listing
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