Surgery Versus Radiosurgery for the Treatment of Single Brain Metastases

Official Title

Feasibility of a Prospective, Randomized Trial Comparing Surgery Versus Radiosurgery for the Treatment of Single Brain Metastases

Summary:

Usually the treatment of a single brain metastasis is surgery or Stereotactic Radiosurgery (SRS). Surgery involves resection of the brain tumour by means of an operation, whereas SRS is treatment consisting of highly focused radiation doses to the tumour. 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 tumours. 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.

Trial Description

Primary Outcome:

  • To determine the feasibility of accrual to a randomized trial of SRS vs Surgery in patients with single brain metastasis.
  • To compare the incidence of recommendation for a second local therapeutic intervention to the treated metastasis at 1 year.
Secondary Outcome:
  • To compare overall survival between the two randomized cohorts.
  • To compare local-recurrence-free survival between the two randomized cohorts.
  • To compare CTCAE v 3.0 neurological outcomes
  • To evaluate difference in neurocognitive outcomes
  • To measure and compare quality of life
  • To determine adverse effects attributable to local therapy
  • To compare medication requirements in each cohorts (steroids, anticonvulsants)
  • To explore potential predictive factors of outcomes
  • To investigate potential biofluid and imaging biomarkers of response
  • To compare ECOG performance status

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society