Observation for Patients With Asymptomatic CNS Metastatic Disease

NCT02866981 | Completed Phase 2

• 1 other identifier: 13-180EX
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer; Metastatic Cancer

Keywords

Brain Metastases

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Quality of life

  Every two months for two years

• Natural History of untreated CNS met

  Every two months for two years

• Type of treatment

  Every two months for two years

• Indication for treatment

  Every two months for two years

• Neurocognitive testing

  Every two months for two years

Study Arms (1)

Observation

EXPERIMENTAL

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

Interventions

Observation OTHER

Observation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Head and Neck
• Gyn
• Prostate
• Breast
• Kidney

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cooper Health System: lead

Study Sites (1)

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis; Brain Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Harry Mazurek, MD

  Cooper University Health System

  STUDY DIRECTOR

• Gregory Kubicek, MD

  Cooper University Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 15, 2016
• Study Start: February 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 9, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)