Observation for Patients With Asymptomatic CNS Metastatic Disease

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Metastatic Cancer
• Intervention / Treatment: Other: Observation

Detailed Description

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
• Enrollment (Actual): 33
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Kaplan-Meier survival analyses	Every two months for two years
CNS treatment-free survival rate	overall survival combined with CNS treatment	Every two months for two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	determined by FACT-Br	Every two months for two years
Natural History of untreated CNS met	Measure the size of CNS target lesion over time	Every two months for two years
Type of treatment	When/if needed	Every two months for two years
Indication for treatment	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	Montreal Cognitive Assessment	Every two months for two years

Collaborators and Investigators

• Sponsor: The Cooper Health System
• Investigators: Study Director: Harry Mazurek, MD, Cooper University Health System; Principal Investigator: Gregory Kubicek, MD, Cooper University Health System

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: August 4, 2016
• First Submitted That Met QC Criteria: August 12, 2016
• First Posted (Estimate): August 15, 2016

Study Record Updates

• Last Update Posted (Actual): May 9, 2018
• Last Update Submitted That Met QC Criteria: May 3, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Brain Metastases
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: 13-180EX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO