Surgery Versus Radiosurgery for the Treatment of Single Brain Metastases

This study has been withdrawn prior to enrollment.
(Recruitment challenges)
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01295970
First received: February 11, 2011
Last updated: June 11, 2013
Last verified: June 2013
  Purpose

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 Intervention
Patients With a Single Brain Metastasis
Procedure: Surgery
Procedure: Stereotactic Radiosurgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility of a Prospective, Randomized Trial Comparing Surgery Versus Radiosurgery for the Treatment of Single Brain Metastases

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • To determine the feasibility of accrual to a randomized trial of SRS vs Surgery in patients with single brain metastasis. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To compare the incidence of recommendation for a second local therapeutic intervention to the treated metastasis at 1 year. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare overall survival between the two randomized cohorts. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To compare local-recurrence-free survival between the two randomized cohorts. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To compare CTCAE v 3.0 neurological outcomes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To evaluate difference in neurocognitive outcomes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To measure and compare quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To determine adverse effects attributable to local therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To compare medication requirements in each cohorts (steroids, anticonvulsants) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To explore potential predictive factors of outcomes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To investigate potential biofluid and imaging biomarkers of response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To compare ECOG performance status [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: April 2011
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01295970

Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Gelareh Zadeh, MD University Health Network, Toronoto Western Hospital
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01295970     History of Changes
Other Study ID Numbers: UHN REB 10-0486-C
Study First Received: February 11, 2011
Last Updated: June 11, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
Surgery of the brain
Radiosurgery
Brain Metastasis

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014