Surgery Versus Radiosurgery for the Treatment of Single Brain Metastases

NCT01295970 | Withdrawn DMC

• 1 other identifier: UHN REB 10-0486-C
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Patients With a Single Brain Metastasis

Keywords

Surgery of the brain; Radiosurgery; Brain Metastasis

Outcome Measures

Primary Outcomes (2)

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

  2 years

• To compare the incidence of recommendation for a second local therapeutic intervention to the treated metastasis at 1 year.

  2 years

Secondary Outcomes (10)

• To compare overall survival between the two randomized cohorts.

  2 years

• To compare local-recurrence-free survival between the two randomized cohorts.

  2 years

• To compare CTCAE v 3.0 neurological outcomes

  2 years

• To evaluate difference in neurocognitive outcomes

  2 years

• To measure and compare quality of life

  2 years

Study Arms (2)

Radiosurgery (SRS)

ACTIVE COMPARATOR

Procedure: Stereotactic Radiosurgery

Surgery

ACTIVE COMPARATOR

Procedure: Surgery

Interventions

Surgery PROCEDURE

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.

Surgery

Stereotactic Radiosurgery PROCEDURE

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.

Radiosurgery (SRS)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy proven malignancy (original biopsy is adequate as long as the brain imaging is consistent with brain metastases)
• Patients \> 18 years
• A contrast-enhanced MRI demonstrating the presence a single brain metastases \<3cm performed within one month prior to registration
• Life expectancy \> 3 months
• RPA Class 1 and RPA Class 2 patients with stable primary disease
• Patients must have normal organ and marrow function
• 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
• ECOG Performance Status 0-2
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

• Have tumor(s) in the midbrain, pons, or medulla, in eloquent cortex
• Have tumors within 10 millimeters of the optic apparatus (nerves and chiasm) or the area postrema
• Be poor operative candidates from an anesthetic point of view secondary to other major medical illnesses
• Have a coagulopathy demonstrated by an abnormal prothrombin time, activated partial thromboplastin time, or thrombocytopenia (platelet count less that 150,000 platelets/mm3)
• Have radiographic or cerebrospinal fluid specimen evidence of widespread leptomeningeal metastasis
• Significant psychiatric impairments which, in the opinion of the investigators, will interfere with the proper administration or completion of the protocol
• Acute or untreated infections (viral, bacterial or fungal)
• Be prisoners or other institutionalized individuals
• Have a diagnosis of germ cell tumor, lymphoma or small cell lung cancer 10.Concurrent chemotherapy or molecularly targeted anti-cancer therapy
• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Surgical Procedures, Operative; Radiosurgery

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Investigative Techniques

Study Officials

• Gelareh Zadeh, MD

  University Health Network, Toronoto Western Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2011
• First Posted: February 15, 2011
• Study Start: April 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2018
• Last Updated: June 13, 2013

Record last verified: 2013-06