Stereotactic Radiation Therapy in Treating Patients With Brain Metastases

Study Overview
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Brief Summary
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RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This phase II trial is study how well stereotactic radiation therapy works in treating patients with brain metastases

Detailed Description
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OBJECTIVES: Primary To determine the neurological death rate following the initiation of conformal stereotactic radiotherapy in patients with 1-3 brain metastases. Secondary To determine the overall survival rate at 6 months. To determine the progression-free survival rate or brain metastases recurrence rate at 6 months. To determine the time to neurological death, time to systemic death, and Karnofsky decay time. To determine the frequency and severity of adverse events associated with conformal stereotactic radiotherapy. OUTLINE: Patients undergo conformal stereotactic radiotherapy over 5 days to an area including 3 mm around the metastases or the surgical cavity. Patients may receive additional radiotherapy if symptomatic metastases emerge at different sites. After completion of study treatment, patients are followed up at 1 and 2 months and then every 3 months thereafter.

Official Title
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A Phase II Trial of Focal Therapy in the Treatment of Patients With 1-3 Brain Metastases

Conditions
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Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Radiation: Radiation Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histology-confirmed cancer with 1 to 3 symptomatic brain metastases imaged by MRI/CT scans. Have cancer not originating in central nervous system (CNS) Karnofsky score of at least 60 Given written consent At least 18 years of age Exclusion Criteria: Prior whole brain radiotherapy or prior focal radiotherapy of the metastasis/es considered for this trial. Certain radiosensitive primary tumors such as small cell lung cancer, germ cell tumors, lymphoma, leukemia or multiple myeloma.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (conformal stereotactic radiation therapy)<br>Patients undergo conformal stereotatic radiation | Radiation: Radiation Therapy<br>* Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days.<br>* Other names: Radiation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients Dying of Neurological Death, Defined as Dying With Progressive Neurological Dysfunction Regardless of Systemic Disease Status | Neurological death is defined as dying with progressive neurological dysfunction regardless of systemic disease status. Patients wtih severe neurological disability who die of intercurrent illness will also be considered to have died of neurological death. | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival (PFS) | Time from enrollment to first date of progressive or recurrent disease. Worsening of neurological symptoms is considered indicative of neurological disease progression. Patients who die of disease-related or treatment-related causes will be considered to have progressed at their date of death; i.e., not be considered 'censored'. PFS will be considered censored only if no progression is noted or if the patient dies of a clearly non-cancer-related event such as accident. | Up to 5 years | 
| Time to Neurological Death | Time from enrollment to date of death directly due to brain metastases. Deaths from other causes including hemorrhage or infection will be considered 'censored' observations in the setting of neurologic improvement or stabilization. If the patient dies of any cause with worsening of neurologic symptoms, the death will be counted as an 'event' or neurological death. | From time of enrollment up to 5 years | 
| Time to Systemic Death | Descriptive analysis will be conducted using Kaplan-Meier survival analysis | From time of enrollment up to 5 years | 
| Karnofsky Decay Time | Time from enrollment to the date the patient's Karnofsky performance score drops below 60. If the patient dies of any cause with no documentation of a drop in their Karnofsky score to less than 60, the date of death will be used as the date of worsening of the Karnofsky score. A patient with a Karnofsky score of 60 or greater requires occasional assistance, but is able to care for most of his/her needs. A patient's Karnofsky decay time will be considered censored if the patient is still under follow up with a Karnofsky score of 60 or greater and if the patient dies of a non-cancer-related cause. | From time of enrollment up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tumors metastatic to brain, unspecified adult solid tumor, protocol specific