CancerPhase 2NCT02866981
Observation for Patients With Asymptomatic CNS Metastatic Disease
A Phase 2 study testing Observation in people with Cancer and Metastatic Cancer, run by Cooper Norcross Health at 1 site in United States.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer, Metastatic Cancer
- What is being tested?
- Observation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to 1 Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cooper University Hospital
Camden, New Jersey, 08103
About this study
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.
Read the 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
- Conditions
- Cancer, Metastatic Cancer
- Being tested
- Observation
- Keywords
- Brain Metastases
- Medical subject headings
- Neoplasms, Neoplasm Metastasis, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Kaplan-Meier survival analyses
Measured: Every two months for two years
CNS treatment-free survival rate
overall survival combined with CNS treatment
Measured: Every two months for two years
Secondary outcomes (5)
Quality of life
determined by FACT-Br
Measured: Every two months for two years
Natural History of untreated CNS met
Measure the size of CNS target lesion over time
Measured: Every two months for two years
Type of treatment
When/if needed
Measured: 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.
Measured: Every two months for two years
Neurocognitive testing
Montreal Cognitive Assessment
Measured: Every two months for two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startFeb 2014
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cooper Norcross Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harry Mazurek, MD, Study director, Cooper University Health SystemGregory Kubicek, MD, Principal investigator, Cooper University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02866981
- Sponsor's protocol ID
- 13-180EX
- Status last verified
- May 2018
- First submitted
- 4 Aug 2016
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation for Patients With Asymptomatic CNS Metastatic Disease
- ClinicalTrials.gov ID
- NCT02866981
- Acronym / sponsor ID
- 13-180EX
- Conditions
- Cancer, Metastatic Cancer
- Keywords
- Brain Metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Cooper Norcross HealthUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 15 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | Experimental | Other: ObservationPatients that meet all inclusion and exclusion criteria are monitored every 2 months for two years or until a therapeutic intervention is warranted. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation | Other | Observation |
Primary outcome
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
5 secondary outcomes
Quality of life
Time frame: Every two months for two years
Natural History of untreated CNS met
Time frame: Every two months for two years
Type of treatment
Time frame: Every two months for two years
Indication for treatment
Time frame: Every two months for two years
Neurocognitive testing
Time frame: Every two months for two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry Mazurek, MD study director
Cooper University Health System
Gregory Kubicek, MD principal investigator
Cooper University Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Observation in people with Cancer and Metastatic Cancer, run by Cooper Norcross Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Every two months for two years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2018.