Observation for Patients With Asymptomatic CNS Metastatic Disease

Cancer Clinical Trial

Official title:

Observation for Patients With Asymptomatic CNS Metastatic Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02866981
• Other study ID #: 13-180EX
• Status: Completed
• Phase: Phase 2
• Start date: February 2014
• Est. completion date: December 1, 2017

Study information

• Verified date: May 2018
• Source: The Cooper Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Other:
• Observation

Locations

Country	Name	City	State
United States	Cooper University Hospital	Camden	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
The Cooper Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Kaplan-Meier survival analyses	Every two months for two years
Primary	CNS treatment-free survival rate	overall survival combined with CNS treatment	Every two months for two years
Secondary	Quality of life	determined by FACT-Br	Every two months for two years
Secondary	Natural History of untreated CNS met	Measure the size of CNS target lesion over time	Every two months for two years
Secondary	Type of treatment	When/if needed	Every two months for two years
Secondary	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
Secondary	Neurocognitive testing	Montreal Cognitive Assessment	Every two months for two years