Observation for Patients With Asymptomatic CNS Metastatic Disease
3 de mayo de 2018 actualizado por: 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.
Descripción general del estudio
Descripción detallada
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
Tipo de estudio
Intervencionista
Inscripción (Actual)
33
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
New Jersey
-
Camden, New Jersey, Estados Unidos, 08103
- Cooper University Hospital
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Observation
Patients that meet all inclusion and exclusion criteria are monitored every 2 months for two years or until a therapeutic intervention is warranted.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Overall survival
Periodo de tiempo: Every two months for two years
|
Kaplan-Meier survival analyses
|
Every two months for two years
|
|
CNS treatment-free survival rate
Periodo de tiempo: Every two months for two years
|
overall survival combined with CNS treatment
|
Every two months for two years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Quality of life
Periodo de tiempo: Every two months for two years
|
determined by FACT-Br
|
Every two months for two years
|
|
Natural History of untreated CNS met
Periodo de tiempo: Every two months for two years
|
Measure the size of CNS target lesion over time
|
Every two months for two years
|
|
Type of treatment
Periodo de tiempo: Every two months for two years
|
When/if needed
|
Every two months for two years
|
|
Indication for treatment
Periodo de tiempo: 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.
|
Every two months for two years
|
|
Neurocognitive testing
Periodo de tiempo: Every two months for two years
|
Montreal Cognitive Assessment
|
Every two months for two years
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Harry Mazurek, MD, Cooper University Health System
- Investigador principal: Gregory Kubicek, MD, Cooper University Health System
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de febrero de 2014
Finalización primaria (Actual)
1 de diciembre de 2017
Finalización del estudio (Actual)
1 de diciembre de 2017
Fechas de registro del estudio
Enviado por primera vez
4 de agosto de 2016
Primero enviado que cumplió con los criterios de control de calidad
12 de agosto de 2016
Publicado por primera vez (Estimar)
15 de agosto de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
9 de mayo de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
3 de mayo de 2018
Última verificación
1 de mayo de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 13-180EX
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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