NCT02866981

Observation for Patients With Asymptomatic CNS Metastatic Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: The Cooper Health System · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• Cancer
• Metastatic Cancer

Interventions

Type	Name	Description
OTHER	Observation

Timeline

• Start date: 2014-02-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2016-08-15
• Last updated: 2018-05-09

Locations

1 site across 1 country: United States