Observation for Patients With Asymptomatic CNS Metastatic Disease
3 mai 2018 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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
Type d'étude
Interventionnel
Inscription (Réel)
33
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
New Jersey
-
Camden, New Jersey, États-Unis, 08103
- Cooper University Hospital
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Observation
Patients that meet all inclusion and exclusion criteria are monitored every 2 months for two years or until a therapeutic intervention is warranted.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Overall survival
Délai: Every two months for two years
|
Kaplan-Meier survival analyses
|
Every two months for two years
|
|
CNS treatment-free survival rate
Délai: Every two months for two years
|
overall survival combined with CNS treatment
|
Every two months for two years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Quality of life
Délai: Every two months for two years
|
determined by FACT-Br
|
Every two months for two years
|
|
Natural History of untreated CNS met
Délai: Every two months for two years
|
Measure the size of CNS target lesion over time
|
Every two months for two years
|
|
Type of treatment
Délai: Every two months for two years
|
When/if needed
|
Every two months for two years
|
|
Indication for treatment
Délai: 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
Délai: Every two months for two years
|
Montreal Cognitive Assessment
|
Every two months for two years
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Harry Mazurek, MD, Cooper University Health System
- Chercheur principal: Gregory Kubicek, MD, Cooper University Health System
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 février 2014
Achèvement primaire (Réel)
1 décembre 2017
Achèvement de l'étude (Réel)
1 décembre 2017
Dates d'inscription aux études
Première soumission
4 août 2016
Première soumission répondant aux critères de contrôle qualité
12 août 2016
Première publication (Estimation)
15 août 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
9 mai 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 mai 2018
Dernière vérification
1 mai 2018
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 13-180EX
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
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