Patients With a Single Brain Metastasis Clinical Trial
Official title:
Feasibility of a Prospective, Randomized Trial Comparing Surgery Versus Radiosurgery for the Treatment of Single Brain Metastases
| Verified date | June 2013 |
| Source | University Health Network, Toronto |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Ethics Review Committee |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | September 2018 |
| Est. primary completion date | September 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 19 Years and older |
| Eligibility |
Inclusion Criteria: 1. Biopsy proven malignancy (original biopsy is adequate as long as the brain imaging is consistent with brain metastases) 2. Patients > 18 years 3. A contrast-enhanced MRI demonstrating the presence a single brain metastases <3cm performed within one month prior to registration 4. Life expectancy > 3 months 5. RPA Class 1 and RPA Class 2 patients with stable primary disease 6. Patients must have normal organ and marrow function 7. 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 8. ECOG Performance Status 0-2 9. Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: 1. Have tumor(s) in the midbrain, pons, or medulla, in eloquent cortex 2. Have tumors within 10 millimeters of the optic apparatus (nerves and chiasm) or the area postrema 3. Be poor operative candidates from an anesthetic point of view secondary to other major medical illnesses 4. Have a coagulopathy demonstrated by an abnormal prothrombin time, activated partial thromboplastin time, or thrombocytopenia (platelet count less that 150,000 platelets/mm3) 5. Have radiographic or cerebrospinal fluid specimen evidence of widespread leptomeningeal metastasis 6. Significant psychiatric impairments which, in the opinion of the investigators, will interfere with the proper administration or completion of the protocol 7. Acute or untreated infections (viral, bacterial or fungal) 8. Be prisoners or other institutionalized individuals 9. 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University Health Network, Toronto |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To determine the feasibility of accrual to a randomized trial of SRS vs Surgery in patients with single brain metastasis. | 2 years | No | |
| Primary | To compare the incidence of recommendation for a second local therapeutic intervention to the treated metastasis at 1 year. | 2 years | No | |
| Secondary | To compare overall survival between the two randomized cohorts. | 2 years | No | |
| Secondary | To compare local-recurrence-free survival between the two randomized cohorts. | 2 years | No | |
| Secondary | To compare CTCAE v 3.0 neurological outcomes | 2 years | No | |
| Secondary | To evaluate difference in neurocognitive outcomes | 2 years | No | |
| Secondary | To measure and compare quality of life | 2 years | No | |
| Secondary | To determine adverse effects attributable to local therapy | 2 years | No | |
| Secondary | To compare medication requirements in each cohorts (steroids, anticonvulsants) | 2 years | No | |
| Secondary | To explore potential predictive factors of outcomes | 2 years | No | |
| Secondary | To investigate potential biofluid and imaging biomarkers of response | 2 years | No | |
| Secondary | To compare ECOG performance status | 2 years | No |