Metastatic CancerNCT02567643
Stereotactic Radiosurgery (SRS) for Multiple CNS Mets
A study testing Stereotactic Radiosurgery in people with Metastatic Cancer and Brain Metastases, run by The Cooper Health System at 1 site in United States.
Trial summary
This study is designed to determine outcome for patients with 5 or more central nervous system (CNS) metastatic lesions treated with stereotactic radiosurgery (SRS). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metastatic Cancer, Brain Metastases
- What is being tested?
- Stereotactic Radiosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Mar 2017
- Phase
- Interventional
- 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 with 5 to 25 CNS mets that require treatment (note that previous SRS, WBRT, and resection for previous CNS mets is allowed. At time of protocol treatment, patient must have 5 or more new or progressing CNS mets that require treatment, this includes new lesions not before seen or progression of previous lesions.). While definition of new lesions is fairly straightforward, the definition of progression of old lesion is at the discretion of the treating team but it is recommended that progression be defined by a multidisciplinary team (radiation oncologist, neurosurgeon, neuro-radiologist). Note that treatment of tumor bed does not count as treatment of an active lesion.
- For example,
- Patient with 10 lesions in 2010 who had whole brain radiation and now has 2 new lesions and progression of 3 previously noted lesions would be eligible
- Patient with 31 lesions in 2010 who had whole brain radiation and now has 26 stable lesions and progression of 5 lesions is eligible. Although the patient has more than 25 lesions the majority are stable and do not require treatment.
- Patient with 6 brain lesions has surgical resection of one lesion is eligible. Patient will require treatment for 5 lesions. Patient can also have treatment of surgical tumor bed but this does not count towards 5 lesions required for eligibility.
- All lesions < 4 cm in greatest dimension
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- Able to have an MRI with contrast
- MRI within 6 weeks (MRI for eligibility can be done without contrast but planning MRI for radiosurgery will have contrast).
- Patients of child-bearing age must agree to contraception until radiosurgery has been completed.
- Patients able to undergo radiosurgery. Gamma knife radiosurgery is preferred for this protocol but cyberknife can also be used at the discretion of treating physicians.
- Karnofsky Performance Scale (KPS) 50 or better
- 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
- Less than 5 CNS lesions (can have had previously treated lesions by either surgery or SRS, but at time of protocol SRS must have 5 or more untreated lesions).
- More than 25 CNS lesions that require treatment (note that the patient can have had previous metastatic lesions, but at the time of enrollment cannot have more than 25 new lesions).
- For example:
- Patient with 12 brain lesions has whole brain radiation in 2010, on follow-up has progression of 3 lesions is not eligible since less than 5 lesions require treatment.
- Patient with 5 brain lesions has surgical resection of one lesions, patient is not eligible since has less than 5 lesions that require treatment.
- Ineligible primaries Lymphoma Lung (SCLC) that have not had previous whole brain radiation Primary CNS tumors Leptomeningeal disease in CNS
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- Must not have any chemotherapy or targeted therapy within 24 hours prior to SRS
- 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 > 4 cm in any dimension
- KPS 40 or less
- Serious or other life threatening illness as determined by the treating physician
Trial locations and contacts
1 site in 1 country.
United States1 site
MD Anderson Cancer Center at Cooper
Camden, New Jersey, 08103
About this study
Official title: Stereotactic Radiosurgery for Multiple (5+) CNS Metastases
This study is designed to determine outcome for patients with 5 or more central nervous system (CNS) metastatic lesions treated with stereotactic radiosurgery (SRS).
- Conditions
- Metastatic Cancer, Brain Metastases
- Being tested
- Stereotactic Radiosurgery
- Keywords
- Brain, CNS, Metastases
- Medical subject headings
- Neoplasm Metastasis, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic RadiosurgeryRadiation
Also called Gamma Knife, Cyber Knife, SRS
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Radiosurgery | Experimental | Not described Receives: Radiation: Stereotactic Radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 6 months
Distant CNS free survival (new lesions in CNS)
Measured: 6 months
Secondary outcomes (6)
Quality of life (as determined by FACT-Br)
Measured: 6 months
Local control (For CNS, local control refers to treated lesions)
Measured: 6 months
Timing and need for salvage therapy (whole brain radiation or repeat whole brain radiation)
Measured: 6 months
Median dose to whole brain with SRS
Measured: 6 months
Neurocognitive testing (Montreal Cognitive Assessment)
Measured: 6 months
Adverse Events for Safety and Tolerability of treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study startMay 2013
- Primary completionMar 2017 (estimated)
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cooper Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567643
- Sponsor's protocol ID
- 13-032
- Status last verified
- Mar 2017
- First submitted
- 3 Apr 2014
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Radiosurgery for Multiple (5+) CNS Metastases
- ClinicalTrials.gov ID
- NCT02567643
- Acronym / sponsor ID
- 13-032
- Conditions
- Metastatic Cancer, Brain Metastases
- Keywords
- Brain, CNS, Metastases
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Cooper Health SystemUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (actual)
- First posted
- 5 Oct 2015 (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.
This study is designed to determine outcome for patients with 5 or more central nervous system (CNS) metastatic lesions treated with stereotactic radiosurgery (SRS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Radiosurgery | Experimental | Radiation: Stereotactic Radiosurgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (22 listed)
- CNS metastatic disease with 5 to 25 CNS mets that require treatment (note that previous SRS, WBRT, and resection for previous CNS mets is allowed. At time of protocol treatment, patient must have 5 or more new or progressing CNS mets that require treatment, this includes new lesions not before seen or progression of previous lesions.). While definition of new lesions is fairly straightforward, the definition of progression of old lesion is at the discretion of the treating team but it is recommended that progression be defined by a multidisciplinary team (radiation oncologist, neurosurgeon, neuro-radiologist). Note that treatment of tumor bed does not count as treatment of an active lesion.
- For example,
- Patient with 10 lesions in 2010 who had whole brain radiation and now has 2 new lesions and progression of 3 previously noted lesions would be eligible
- Patient with 31 lesions in 2010 who had whole brain radiation and now has 26 stable lesions and progression of 5 lesions is eligible. Although the patient has more than 25 lesions the majority are stable and do not require treatment.
- Patient with 6 brain lesions has surgical resection of one lesion is eligible. Patient will require treatment for 5 lesions. Patient can also have treatment of surgical tumor bed but this does not count towards 5 lesions required for eligibility.
Key exclusion criteria (12 listed)
- Less than 5 CNS lesions (can have had previously treated lesions by either surgery or SRS, but at time of protocol SRS must have 5 or more untreated lesions).
- More than 25 CNS lesions that require treatment (note that the patient can have had previous metastatic lesions, but at the time of enrollment cannot have more than 25 new lesions).
- Patient with 12 brain lesions has whole brain radiation in 2010, on follow-up has progression of 3 lesions is not eligible since less than 5 lesions require treatment.
- Patient with 5 brain lesions has surgical resection of one lesions, patient is not eligible since has less than 5 lesions that require treatment.
- Ineligible primaries Lymphoma Lung (SCLC) that have not had previous whole brain radiation Primary CNS tumors Leptomeningeal disease in CNS
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 |
|---|---|---|
| Stereotactic RadiosurgeryAlso: Gamma Knife, Cyber Knife, SRS | Radiation | Stereotactic Radiosurgery |
Primary outcome
Overall survival
Time frame: 6 months
Distant CNS free survival (new lesions in CNS)
Time frame: 6 months
6 secondary outcomes
Quality of life (as determined by FACT-Br)
Time frame: 6 months
Local control (For CNS, local control refers to treated lesions)
Time frame: 6 months
Timing and need for salvage therapy (whole brain radiation or repeat whole brain radiation)
Time frame: 6 months
Median dose to whole brain with SRS
Time frame: 6 months
Neurocognitive testing (Montreal Cognitive Assessment)
Time frame: 6 months
Adverse Events for Safety and Tolerability of treatment
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Radiosurgery in people with Metastatic Cancer and Brain Metastases, run by The Cooper Health System 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 22 inclusion and 12 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: withdrawn, as of the sponsor's last update on 11 Jan 2022. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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: 6 months). 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 11 Jan 2022.