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Surgery Versus Radiosurgery for the Treatment of Single Brain Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01295970
Recruitment Status : Withdrawn (Recruitment challenges)
First Posted : February 15, 2011
Last Update Posted : June 13, 2013
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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 Procedure: 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.

Primary Outcome Measures :
  1. 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. To compare the incidence of recommendation for a second local therapeutic intervention to the treated metastasis at 1 year. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. To compare overall survival between the two randomized cohorts. [ Time Frame: 2 years ]
  2. To compare local-recurrence-free survival between the two randomized cohorts. [ Time Frame: 2 years ]
  3. To compare CTCAE v 3.0 neurological outcomes [ Time Frame: 2 years ]
  4. To evaluate difference in neurocognitive outcomes [ Time Frame: 2 years ]
  5. To measure and compare quality of life [ Time Frame: 2 years ]
  6. To determine adverse effects attributable to local therapy [ Time Frame: 2 years ]
  7. To compare medication requirements in each cohorts (steroids, anticonvulsants) [ Time Frame: 2 years ]
  8. To explore potential predictive factors of outcomes [ Time Frame: 2 years ]
  9. To investigate potential biofluid and imaging biomarkers of response [ Time Frame: 2 years ]
  10. To compare ECOG performance status [ Time Frame: 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01295970

Sponsors and Collaborators
University Health Network, Toronto
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Principal Investigator: Gelareh Zadeh, MD University Health Network, Toronoto Western Hospital
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Responsible Party: University Health Network, Toronto Identifier: NCT01295970    
Other Study ID Numbers: UHN REB 10-0486-C
First Posted: February 15, 2011    Key Record Dates
Last Update Posted: June 13, 2013
Last Verified: June 2013
Keywords provided by University Health Network, Toronto:
Surgery of the brain
Brain Metastasis
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases