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Observation for Patients With Asymptomatic CNS Metastatic Disease

This study is currently recruiting participants.
Verified August 2016 by The Cooper Health System
Sponsor:
ClinicalTrials.gov Identifier:
NCT02866981
First Posted: August 15, 2016
Last Update Posted: August 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
The Cooper Health System
  Purpose
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.

Condition Intervention Phase
Cancer Metastatic Cancer Other: Observation Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Observation for Patients With Asymptomatic CNS Metastatic Disease

Further study details as provided by The Cooper Health System:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 44
Study Start Date: February 2014
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Gregory Kubicek, MD kubicek-gregory@cooperhealth.edu
Contact: Andrew March, BS 856-342-2460 march-andrew@cooperhealth.edu

Locations
United States, New Jersey
Cooper University Hospital Recruiting
Camden, New Jersey, United States, 08103
Contact: Andrew March, BS    856-342-2460    march-andrew@cooperhealth.edu   
Principal Investigator: Gregory Kubicek, MD         
Sponsors and Collaborators
The Cooper Health System
Investigators
Study Director: Harry Mazurek, MD Cooper University Health System
Principal Investigator: Gregory Kubicek, MD Cooper University Health System
  More Information

Responsible Party: The Cooper Health System
ClinicalTrials.gov Identifier: NCT02866981     History of Changes
Other Study ID Numbers: 13-180EX
First Submitted: August 4, 2016
First Posted: August 15, 2016
Last Update Posted: August 15, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by The Cooper Health System:
Brain Metastases

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes