Patients With a Single Brain MetastasisNCT01295970
Surgery Versus Radiosurgery for the Treatment of Single Brain Metastases
A study testing Surgery and Stereotactic Radiosurgery in people with Patients With a Single Brain Metastasis, run by University Health Network, Toronto.
Trial summary
Usually the treatment of a single brain metastasis is surgery or Stereotactic Radiosurgery (SRS). Surgery involves resection of the brain tumor by means of an operation, whereas SRS is treatment consisting of highly focused radiation doses to the tumor. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Patients With a Single Brain Metastasis
- What is being tested?
- Surgery and 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
- No sites listed yet
- Study dates
- Apr 2011to Sep 2018
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy proven malignancy (original biopsy is adequate as long as the brain imaging is consistent with brain metastases)
- Patients > 18 years
- A contrast-enhanced MRI demonstrating the presence a single brain metastases <3cm performed within one month prior to registration
- Life expectancy > 3 months
- RPA Class 1 and RPA Class 2 patients with stable primary disease
- Patients must have normal organ and marrow function
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- Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- ECOG Performance Status 0-2
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Have tumor(s) in the midbrain, pons, or medulla, in eloquent cortex
- Have tumors within 10 millimeters of the optic apparatus (nerves and chiasm) or the area postrema
- Be poor operative candidates from an anesthetic point of view secondary to other major medical illnesses
- Have a coagulopathy demonstrated by an abnormal prothrombin time, activated partial thromboplastin time, or thrombocytopenia (platelet count less that 150,000 platelets/mm3)
- Have radiographic or cerebrospinal fluid specimen evidence of widespread leptomeningeal metastasis
- Significant psychiatric impairments which, in the opinion of the investigators, will interfere with the proper administration or completion of the protocol
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- Acute or untreated infections (viral, bacterial or fungal)
- Be prisoners or other institutionalized individuals
- Have a diagnosis of germ cell tumor, lymphoma or small cell lung cancer 10.Concurrent chemotherapy or molecularly targeted anti-cancer therapy
- 11.Allergy to Gadolinium 12.Imminent brain herniation, massive peritumoural oedema or hydrocephalus 13.Have any metallic implant that would exclude the possibility of having a brain MRI
About this study
Official title: Feasibility of a Prospective, Randomized Trial Comparing Surgery Versus Radiosurgery for the Treatment of Single Brain Metastases
Usually the treatment of a single brain metastasis is surgery or Stereotactic Radiosurgery (SRS). Surgery involves resection of the brain tumor by means of an operation, whereas SRS is treatment consisting of highly focused radiation doses to the tumor. These two treatment modalities are both widely used, well established, and proven to improve survival, but so far, no study has been done to directly compare the efficacy of one over the other. Neither treatment in itself is considered to be experimental and both have been shown to provide benefits to patients with metastatic brain tumors. The aim of this study is to determine which two modalities are better for local control and improving quality of life.
Patients who consent to this study will be randomized to either receive surgery or Radiosurgery in the treatment of single brain metastases. The study seeks to recruit 12 patient to each group. Patients will be in this study for up to five years from the time of the treatment finished. This will include follow-up visits at 4 weeks after the procedure and then every 3 months after the procedure up to 5 years.
- Conditions
- Patients With a Single Brain Metastasis
- Being tested
- Surgery, Stereotactic Radiosurgery
- Keywords
- Surgery of the brain, Radiosurgery, Brain Metastasis
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Prior to surgery, patients will have placement of scalp fiducials and undergo a contrast enhanced MRI scan. Once the patient is anesthetized or sedated, the head will be secured with a head frame and scalp fiducials will be registered to the stereotactic neuronavigation system. The tumor will then be resected and the patient will be taken to the recovery unit.
Stereotactic RadiosurgeryProcedure or surgery
This will be delivered using Gamma Knife technology. Patients randomized to this arm will be fitted with a stereotactic head-frame for stereotactic localization of brain metastases.
| Study group | Role | What they receive |
|---|---|---|
| Radiosurgery (SRS) | Active comparator | Not described Receives: Procedure: Stereotactic Radiosurgery |
| Surgery | Active comparator | Not described Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the feasibility of accrual to a randomized trial of SRS vs Surgery in patients with single brain metastasis.
Measured: 2 years
To compare the incidence of recommendation for a second local therapeutic intervention to the treated metastasis at 1 year.
Measured: 2 years
Secondary outcomes (10)
To compare overall survival between the two randomized cohorts.
Measured: 2 years
To compare local-recurrence-free survival between the two randomized cohorts.
Measured: 2 years
To compare CTCAE v 3.0 neurological outcomes
Measured: 2 years
To evaluate difference in neurocognitive outcomes
Measured: 2 years
To measure and compare quality of life
Measured: 2 years
To determine adverse effects attributable to local therapy
Measured: 2 years
To compare medication requirements in each cohorts (steroids, anticonvulsants)
Measured: 2 years
To explore potential predictive factors of outcomes
Measured: 2 years
To investigate potential biofluid and imaging biomarkers of response
Measured: 2 years
To compare ECOG performance status
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2011 (estimated)
- Study startApr 2011
- Primary completionSep 2014 (estimated)
- Study completionSep 2018 (estimated)
Why it stopped: Recruitment challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With a Single Brain MetastasisStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gelareh Zadeh, MD, Principal investigator, University Health Network, Toronoto Western Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295970
- Sponsor's protocol ID
- UHN REB 10-0486-C
- Status last verified
- Jun 2013
- First submitted
- 11 Feb 2011
- Last updated
- 13 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Prospective, Randomized Trial Comparing Surgery Versus Radiosurgery for the Treatment of Single Brain Metastases
- ClinicalTrials.gov ID
- NCT01295970
- Acronym / sponsor ID
- UHN REB 10-0486-C
- Conditions
- Patients With a Single Brain Metastasis
- Keywords
- Surgery of the brain, Radiosurgery, Brain Metastasis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment challenges
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 15 Feb 2011 (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.
Usually the treatment of a single brain metastasis is surgery or Stereotactic Radiosurgery (SRS). Surgery involves resection of the brain tumor by means of an operation, whereas SRS is treatment consisting of highly focused radiation doses to the tumor. These two treatment modalities are both widely used, well established, and proven to improve survival, but so far, no study has been done to directly compare the efficacy of one over the other. Neither treatment in itself is considered to be experimental and both have been shown to provide benefits to patients with metastatic brain tumors. The aim of this study is to determine which two modalities are better for local control and improving quality of life.
Patients who consent to this study will be randomized to either receive surgery or Radiosurgery in the treatment of single brain metastases. The study seeks to recruit 12 patient to each group. Patients will be in this study for up to five years from the time of the treatment finished. This will include follow-up visits at 4 weeks after the procedure and then every 3 months after the procedure up to 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiosurgery (SRS) | Active comparator | Procedure: Stereotactic Radiosurgery |
| Surgery | Active comparator | Procedure: Surgery |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Biopsy proven malignancy (original biopsy is adequate as long as the brain imaging is consistent with brain metastases)
- Patients > 18 years
- A contrast-enhanced MRI demonstrating the presence a single brain metastases <3cm performed within one month prior to registration
- Life expectancy > 3 months
- RPA Class 1 and RPA Class 2 patients with stable primary disease
Key exclusion criteria (10 listed)
- Have tumor(s) in the midbrain, pons, or medulla, in eloquent cortex
- Have tumors within 10 millimeters of the optic apparatus (nerves and chiasm) or the area postrema
- Be poor operative candidates from an anesthetic point of view secondary to other major medical illnesses
- Have a coagulopathy demonstrated by an abnormal prothrombin time, activated partial thromboplastin time, or thrombocytopenia (platelet count less that 150,000 platelets/mm3)
- Have radiographic or cerebrospinal fluid specimen evidence of widespread leptomeningeal metastasis
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 |
|---|---|---|
| SurgeryPrior to surgery, patients will have placement of scalp fiducials and undergo a contrast enhanced MRI scan. Once the patient is anesthetized or sedated, the head will be secured with a head frame and scalp fiducials will be registered to the stereotactic neuronavigation system. The tumor will then be resected and the patient will be taken to the recovery unit. | Procedure or surgery | Surgery |
| Stereotactic RadiosurgeryThis will be delivered using Gamma Knife technology. Patients randomized to this arm will be fitted with a stereotactic head-frame for stereotactic localization of brain metastases. | Procedure or surgery | Radiosurgery (SRS) |
Primary outcome
To determine the feasibility of accrual to a randomized trial of SRS vs Surgery in patients with single brain metastasis.
Time frame: 2 years
To compare the incidence of recommendation for a second local therapeutic intervention to the treated metastasis at 1 year.
Time frame: 2 years
10 secondary outcomes
To compare overall survival between the two randomized cohorts.
Time frame: 2 years
To compare local-recurrence-free survival between the two randomized cohorts.
Time frame: 2 years
To compare CTCAE v 3.0 neurological outcomes
Time frame: 2 years
To evaluate difference in neurocognitive outcomes
Time frame: 2 years
To measure and compare quality of life
Time frame: 2 years
To determine adverse effects attributable to local therapy
Time frame: 2 years
To compare medication requirements in each cohorts (steroids, anticonvulsants)
Time frame: 2 years
To explore potential predictive factors of outcomes
Time frame: 2 years
To investigate potential biofluid and imaging biomarkers of response
Time frame: 2 years
To compare ECOG performance status
Time frame: 2 years
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 13 Jun 2013.
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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.
Gelareh Zadeh, MD principal investigator
University Health Network, Toronoto Western Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Surgery and Stereotactic Radiosurgery in people with Patients With a Single Brain Metastasis, run by University Health Network, Toronto.
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 9 inclusion and 10 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 13 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
To determine the feasibility of accrual to a randomized trial of SRS vs Surgery in patients with single brain metastasis. (time frame: 2 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 13 Jun 2013.