- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01295970
Surgery Versus Radiosurgery for the Treatment of Single Brain Metastases
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Radiosurgery (SRS)
|
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.
|
ACTIVE_COMPARATOR: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the feasibility of accrual to a randomized trial of SRS vs Surgery in patients with single brain metastasis.
Time Frame: 2 years
|
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
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To compare overall survival between the two randomized cohorts.
Time Frame: 2 years
|
2 years
|
To compare local-recurrence-free survival between the two randomized cohorts.
Time Frame: 2 years
|
2 years
|
To compare CTCAE v 3.0 neurological outcomes
Time Frame: 2 years
|
2 years
|
To evaluate difference in neurocognitive outcomes
Time Frame: 2 years
|
2 years
|
To measure and compare quality of life
Time Frame: 2 years
|
2 years
|
To determine adverse effects attributable to local therapy
Time Frame: 2 years
|
2 years
|
To compare medication requirements in each cohorts (steroids, anticonvulsants)
Time Frame: 2 years
|
2 years
|
To explore potential predictive factors of outcomes
Time Frame: 2 years
|
2 years
|
To investigate potential biofluid and imaging biomarkers of response
Time Frame: 2 years
|
2 years
|
To compare ECOG performance status
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Gelareh Zadeh, MD, University Health Network, Toronoto Western Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UHN REB 10-0486-C
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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