Observation for Patients With Asymptomatic CNS Metastatic Disease
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|ClinicalTrials.gov Identifier: NCT02866981|
Recruitment Status : Recruiting
First Posted : August 15, 2016
Last Update Posted : August 15, 2016
|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)|
|Estimated Enrollment :||44 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|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||January 2018|
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866981
|Contact: Gregory Kubicek, MDemail@example.com|
|Contact: Andrew March, BSfirstname.lastname@example.org|
|United States, New Jersey|
|Cooper University Hospital||Recruiting|
|Camden, New Jersey, United States, 08103|
|Contact: Andrew March, BS 856-342-2460 email@example.com|
|Principal Investigator: Gregory Kubicek, MD|
|Study Director:||Harry Mazurek, MD||Cooper University Health System|
|Principal Investigator:||Gregory Kubicek, MD||Cooper University Health System|