Stereotactic Radiosurgery After Surgery in Treating Patients With Brain Metastases

Phase 2TerminatedNCT00814463

Duke University1 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Cancer Unspecified Adult Solid Tumor, Protocol Specific

Interventions

MMSEBEHAVIORAL

Neurocognitive function via MMSE done every 3 months for length of study.

QOL via FACT-BrBEHAVIORAL

Quality of Life via FACT-BR every 3 months for length of study.

MRIPROCEDURE

MRI done every 3 months for the length of the study.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age \>18 years of age. 2. 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. 3. Patient must be Radiation Therapy Oncology Group (RTOG) recursive partitioning analysis (RPA) Class 1 or 2. 4. Life expectancy of at least 3 months. Exclusion Criteria: 1. Radiographic or cytologic evidence of leptomeningeal disease. 2. Patient with incomplete or partial resection. 3. Primary lesion with radiosensitive histology (i.e., small cell carcinoma, germ-cell tumors, lymphoma, leukemia, and multiple myeloma). 4. Patients with a resection cavity \> 4 cm in maximal extent in any plane on contrasted MRI scan. 5. Lesion located in anatomic regions which are not amenable to SRS including the brain stem and optic apparatus. 6. Pregnant or need to breast feed during the study period. 7. Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness. 8. Brain surgery other than for resection of metastasis. 9. Previous brain radiotherapy. 10. Contraindication to SRS, WBRT, or MRI.

Locations (1)

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Recurrence Rate at the Surgical Site as Measured by MRI

The number of months for local recurrence via MRI

Time frame: 12 months

Secondary Outcomes

Rate of Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery

Time frame: 12 months

Rate of New Brain Metastases Outside of the Adjuvant SRS Site

Time frame: 12 months

Quality of Life as Measured by the FACT-Br Subscales

Time frame: Every 3 months for 12 months

Preservation of Neurocognitive Function as Measured by the Mini-Mental State Exam

Time frame: 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)

Time frame: 12 months

Rate of Death Due to Neurologic Causes

Time frame: 12 months

Overall Survival

Time frame: 12 months

Data from ClinicalTrials.gov

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