Surgery Versus Radiosurgery for the Treatment of Single Brain Metastases

NCT ID: NCT01295970

Last Updated: 2013-06-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2018-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiosurgery (SRS)

Group Type: ACTIVE_COMPARATOR

Stereotactic Radiosurgery

Intervention Type: 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.

Surgery

Group Type: ACTIVE_COMPARATOR

Surgery

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gelareh Zadeh, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronoto Western Hospital

Other Identifiers

UHN REB 10-0486-C

Identifier Type: -

Identifier Source: org_study_id