Observation for Patients With Asymptomatic CNS Metastatic Disease
3 mei 2018 bijgewerkt door: The Cooper Health System
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.
Studie Overzicht
Gedetailleerde beschrijving
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
Studietype
Ingrijpend
Inschrijving (Werkelijk)
33
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
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New Jersey
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Camden, New Jersey, Verenigde Staten, 08103
- Cooper University Hospital
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Observation
Patients that meet all inclusion and exclusion criteria are monitored every 2 months for two years or until a therapeutic intervention is warranted.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Overall survival
Tijdsspanne: Every two months for two years
|
Kaplan-Meier survival analyses
|
Every two months for two years
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|
CNS treatment-free survival rate
Tijdsspanne: Every two months for two years
|
overall survival combined with CNS treatment
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Every two months for two years
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Quality of life
Tijdsspanne: Every two months for two years
|
determined by FACT-Br
|
Every two months for two years
|
|
Natural History of untreated CNS met
Tijdsspanne: Every two months for two years
|
Measure the size of CNS target lesion over time
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Every two months for two years
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Type of treatment
Tijdsspanne: Every two months for two years
|
When/if needed
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Every two months for two years
|
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Indication for treatment
Tijdsspanne: Every two months for two years
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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.
|
Every two months for two years
|
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Neurocognitive testing
Tijdsspanne: Every two months for two years
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Montreal Cognitive Assessment
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Every two months for two years
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Harry Mazurek, MD, Cooper University Health System
- Hoofdonderzoeker: Gregory Kubicek, MD, Cooper University Health System
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 februari 2014
Primaire voltooiing (Werkelijk)
1 december 2017
Studie voltooiing (Werkelijk)
1 december 2017
Studieregistratiedata
Eerst ingediend
4 augustus 2016
Eerst ingediend dat voldeed aan de QC-criteria
12 augustus 2016
Eerst geplaatst (Schatting)
15 augustus 2016
Updates van studierecords
Laatste update geplaatst (Werkelijk)
9 mei 2018
Laatste update ingediend die voldeed aan QC-criteria
3 mei 2018
Laatst geverifieerd
1 mei 2018
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 13-180EX
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
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