Observation for Patients With Asymptomatic CNS Metastatic Disease
|ClinicalTrials.gov Identifier: NCT02866981|
Recruitment Status : Completed
First Posted : August 15, 2016
Last Update Posted : May 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cancer Metastatic Cancer||Other: Observation||Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Observation for Patients With Asymptomatic CNS Metastatic Disease|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||December 1, 2017|
|Actual Study Completion Date :||December 1, 2017|
Patients that meet all inclusion and exclusion criteria are monitored every 2 months for two years or until a therapeutic intervention is warranted.
- Overall survival [ Time Frame: Every two months for two years ]Kaplan-Meier survival analyses
- CNS treatment-free survival rate [ Time Frame: Every two months for two years ]overall survival combined with CNS treatment
- Quality of life [ Time Frame: Every two months for two years ]determined by FACT-Br
- Natural History of untreated CNS met [ Time Frame: Every two months for two years ]Measure the size of CNS target lesion over time
- Type of treatment [ Time Frame: Every two months for two years ]When/if needed
- Indication for treatment [ Time Frame: Every two months for two years ]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 [ Time Frame: Every two months for two years ]Montreal Cognitive Assessment
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866981
|United States, New Jersey|
|Cooper University Hospital|
|Camden, New Jersey, United States, 08103|
|Study Director:||Harry Mazurek, MD||Cooper University Health System|
|Principal Investigator:||Gregory Kubicek, MD||Cooper University Health System|