PilotStudyAssessSafeActiveSurveillancApproachLocalThe Pa w/BrainMetsUndergoinCNSPenetratSystemicThe
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of California, Irvine
About this trial
This is a Pilot clinical trial determining the safety of an active surveillance approach to local therapy in subjects with brain metastases. These are subjects who are undergoing CNS-penetrating systemic therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients must have histologically or cytologically confirmed metastatic non-hematologic malignancy.
Patients must have at least one new or progressive brain metastasis that has not received prior local therapy (surgery or radiation therapy).
Patients must have no active brain metastasis >3cm in size.
Leptomeningeal disease is permitted
Disqualifiers
Patients who have only progressive growth of brain lesions that have previously been treated with surgery or radiation therapy.
Patients with active symptomatic brain metastases.
Patients requiring corticosteroids, anticonvulsants, or other palliative medications related to brain metastases.
Patients with conditions that exclude them from undergoing magnetic resonance imaging.
Trial population
Patients with brain metastases undergoing CNS-penetrating systemic therapy
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
12 Participants
are grouped into 1 trial groupGroup A: SingleArm
Trial outcomes
Primary outcomes
1
Feasibility of Enrolling Patients
Feasibility of enrolling patients as measured by percentage of patients enrolled compared to the anticipated study accrual.
Time frame
1 year2
Feasibility of completing required surveillance imaging
Feasibility of completing required surveillance imaging as measured by percentage of enrolled patients that complete surveillance imaging.
Time frame
1 year3
Feasibility of administering Cognitive Assessments
Feasibility of completing required Cognitive Assessments as measured by percentage of enrolled patients that complete QOL and Cognitive Assessments..
Time frame
1 year4
Feasibility of administering QOL Questionnaires
Feasibility of completing required Quality of Life (QOL) Questionnaires as measured by percentage of enrolled patients that complete QOL and Cognitive Assessments..
Time frame
1 yearSecondary outcomes
1
Incidence of pre-defined safety events
Number of subjects who experience incidence of pre-defined safety events associated with progression of intracranial disease while on systemic therapy
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov