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

19 Years
Not Enrolling
Patients With a Single Brain Metastasis

Thank you

Trial Information

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

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

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the feasibility of accrual to a randomized trial of SRS vs Surgery in patients with single brain metastasis.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Gelareh Zadeh, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Toronoto Western Hospital


Canada: Ethics Review Committee

Study ID:

UHN REB 10-0486-C



Start Date:

April 2011

Completion Date:

September 2018

Related Keywords:

  • Patients With a Single Brain Metastasis
  • Surgery of the brain
  • Radiosurgery
  • Brain Metastasis
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Brain Neoplasms