Back to results

Surgery Versus Radiosurgery for the Treatment of Single Brain Metastases

Primary Purpose

Patients With a Single Brain Metastasis

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Surgery

Stereotactic Radiosurgery

About this trial

This is an interventional treatment trial for Patients With a Single Brain Metastasis focused on measuring Surgery of the brain, Radiosurgery, Brain Metastasis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Radiosurgery (SRS)

Surgery

Arm Description

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

To compare overall survival between the two randomized cohorts.

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

To compare CTCAE v 3.0 neurological outcomes

To evaluate difference in neurocognitive outcomes

To measure and compare quality of life

To determine adverse effects attributable to local therapy

To compare medication requirements in each cohorts (steroids, anticonvulsants)

To explore potential predictive factors of outcomes

To investigate potential biofluid and imaging biomarkers of response

To compare ECOG performance status

Full Information

NCT ID

NCT01295970

First Posted

February 11, 2011

Last Updated

June 11, 2013

Sponsor

University Health Network, Toronto

1. Study Identification

Unique Protocol Identification Number

NCT01295970

Brief Title

Surgery Versus Radiosurgery for the Treatment of Single Brain Metastases

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Withdrawn

Why Stopped

Recruitment challenges

Study Start Date

April 2011 (undefined)

Primary Completion Date

September 2014 (Anticipated)

Study Completion Date

September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Health Network, Toronto

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patients With a Single Brain Metastasis

Keywords

Surgery of the brain, Radiosurgery, Brain Metastasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Radiosurgery (SRS)

Arm Type

Active Comparator

Arm Title

Surgery

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

Surgery

Intervention Description

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

Intervention Name(s)

Stereotactic Radiosurgery

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

2 years

Title

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 Measure Information:

Title

To compare overall survival between the two randomized cohorts.

Time Frame

2 years

Title

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

Time Frame

2 years

Title

To compare CTCAE v 3.0 neurological outcomes

Time Frame

2 years

Title

To evaluate difference in neurocognitive outcomes

Time Frame

2 years

Title

To measure and compare quality of life

Time Frame

2 years

Title

To determine adverse effects attributable to local therapy

Time Frame

2 years

Title

To compare medication requirements in each cohorts (steroids, anticonvulsants)

Time Frame

2 years

Title

To explore potential predictive factors of outcomes

Time Frame

2 years

Title

To investigate potential biofluid and imaging biomarkers of response

Time Frame

2 years

Title

To compare ECOG performance status

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gelareh Zadeh, MD

Organizational Affiliation

University Health Network, Toronoto Western Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Surgery Versus Radiosurgery for the Treatment of Single Brain Metastases

We'll reach out to this number within 24 hrs