Surgery Versus Radiosurgery for the Treatment of Single Brain Metastases
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|ClinicalTrials.gov Identifier: NCT01295970|
Recruitment Status : Withdrawn (Recruitment challenges)
First Posted : February 15, 2011
Last Update Posted : June 13, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Patients With a Single Brain Metastasis||Procedure: Surgery Procedure: Stereotactic Radiosurgery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility of a Prospective, Randomized Trial Comparing Surgery Versus Radiosurgery for the Treatment of Single Brain Metastases|
|Study Start Date :||April 2011|
|Estimated Primary Completion Date :||September 2014|
|Estimated Study Completion Date :||September 2018|
|Active Comparator: Radiosurgery (SRS)||
Procedure: Stereotactic Radiosurgery
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.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01295970
|Principal Investigator:||Gelareh Zadeh, MD||University Health Network, Toronoto Western Hospital|