Stereotactic Radiosurgery After Surgery in Treating Patients With Brain Metastases

Study Overview
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Brief Summary
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RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving stereotactic radiosurgery after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well stereotactic radiosurgery works in treating patients with brain metastases.

Detailed Description
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OBJECTIVES: Primary To estimate the rate of recurrence at the surgical site in patients with brain metastases treated with adjuvant stereotactic radiosurgery (SRS) compared with historical data documenting recurrence at the surgical site after surgery and whole brain radiotherapy (WBRT). Secondary To estimate the rate of salvage WBRT, SRS, or surgery in patients treated with adjuvant SRS alone. To estimate the rate of new brain metastases outside of the adjuvant SRS site. To estimate patient quality of life after adjuvant SRS alone. To assess the effect of surgical intervention and SRS on the preservation of neurocognitive functioning in these patients. To determine the clinical significance (if any) of locally recurrent brain metastases at the time of their occurrence (mass effect, cognitive functioning, and other symptoms) in these patients. To estimate the rate of death due to neurologic causes, defined as death attributable to the progression of neurological disease. To estimate the overall survival of these patients. OUTLINE: Patients undergo stereotactic radiosurgery over 30-90 minutes. Quality of life and neurocognitive function are assessed periodically. After completion of study therapy, patients are followed every 3 months for 1 year and then every 6 months for 1 year.

Official Title
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Phase II Single-arm Study of Post-operative Stereotactic Radiosurgery for Brain Metastases.

Conditions
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Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Behavioral: MMSE
* Behavioral: QOL via FACT-Br
* Procedure: MRI
* Radiation: Post-operative SRS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 years of age. Gross total resection (as verified by the lack of any enhancement in the resection cavity on post-operative MRI) of single brain metastasis confirmed by histology. Patients with up to 4 metastases are eligible if the largest mass is amenable to surgical resection and all non-resected masses are amenable to SRS. Patient must be Radiation Therapy Oncology Group (RTOG) recursive partitioning analysis (RPA) Class 1 or 2. Life expectancy of at least 3 months. Exclusion Criteria: Radiographic or cytologic evidence of leptomeningeal disease. Patient with incomplete or partial resection. Primary lesion with radiosensitive histology (i.e., small cell carcinoma, germ-cell tumors, lymphoma, leukemia, and multiple myeloma). Patients with a resection cavity > 4 cm in maximal extent in any plane on contrasted MRI scan. Lesion located in anatomic regions which are not amenable to SRS including the brain stem and optic apparatus. Pregnant or need to breast feed during the study period. Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness. Brain surgery other than for resection of metastasis. Previous brain radiotherapy. Contraindication to SRS, WBRT, or MRI.

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 |
| --- | --- |
| Active Comparator: Post-operative SRS<br>All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study. | Behavioral: MMSE<br>* Neurocognitive function via MMSE done every 3 months for length of study.<br>* Other names: Mini-Mental Status Exam;Behavioral: QOL via FACT-Br<br>* Quality of Life via FACT-BR every 3 months for length of study.<br>* Other names: Functional Assessment of Cancer Therapy - Brain;Procedure: MRI<br>* MRI done every 3 months for the length of the study.<br>* Other names: Magnetic Resonance Imagine;Radiation: Post-operative SRS<br>* Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions.<br>* Other names: SRS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence Rate at the Surgical Site as Measured by MRI | The number of months for local recurrence via MRI | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery |  | 12 months | 
| Rate of New Brain Metastases Outside of the Adjuvant SRS Site |  | 12 months | 
| Quality of Life as Measured by the FACT-Br Subscales |  | Every 3 months for 12 months | 
| Preservation of Neurocognitive Function as Measured by the Mini-Mental State Exam |  | Every 3 months for 12 months. | 
| Clinical Significance (if Any) of Locally Recurrent Brain Metastasis at the Time of Their Occurrence (Mass Effect, Cognitive Functioning, and Other Symptoms) |  | 12 months | 
| Rate of Death Due to Neurologic Causes |  | 12 months | 
| Overall Survival |  | 12 months | 

 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