Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Durham, North Carolina 27710


Purpose:

RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving stereotactic radiosurgery before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well stereotactic radiosurgery works in treating patients with brain metastases.


Study summary:

OBJECTIVES: Primary - To estimate the rate of recurrence at the surgical site in patients with brain metastases treated with neoadjuvant stereotactic radiosurgery (SRS) compared with historical data documenting recurrence at the surgical site after surgical resection and whole-brain radiotherapy (WBRT). Secondary - To estimate the rate of salvage WBRT, SRS, or surgery in patients treated with neoadjuvant SRS alone. - To determine the volume of adjacent normal brain parenchyma irradiated in these patients. - To estimate the rate of new brain metastases outside of the neoadjuvant SRS site in these patients. - To estimate the quality of life of these patients after neoadjuvant SRS alone. - To assess the effect of SRS and surgical intervention on the preservation of neurocognitive functioning in these patients. - To determine the clinical significance (mass effect, cognitive functioning, and other symptoms) of locally recurrent brain metastases at the time of their occurrence in these patients. - To estimate the rate of death due to neurologic causes, defined as death attributable to the progression of neurological disease, in these patients. - To estimate the overall survival of these patients. OUTLINE: Patients undergo stereotactic radiosurgery over 30 to 90 minutes. Approximately 2-4 weeks later, patients undergo surgical resection of brain metastasis. Quality of life and neurocognitive function are assessed periodically using the FACT-Br subscales and Mini-Mental State Exam. After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 1 year.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of brain metastases from an extracranial primary site - Tumor ≤ 4 cm in maximal extent in any plane on contrast MRI - Scheduled to undergo gross total resection of a single brain metastasis confirmed by histology - Up to 4 metastases allowed provided the largest mass is amenable to surgical resection and all non-resected masses are amenable to stereotactic radiosurgery (SRS) - RTOG Recursive Partitioning Analysis (RPA) class 1 or 2, as defined by the following: - RPA class 1: Karnofsky performance status (KPS) 70-100%; age < 65 years; controlled primary disease; and no extracranial metastatic disease - RPA class 2: KPS 70-100%; uncontrolled primary disease; and/or extracranial metastatic disease - No lesion located in anatomic regions that are not amenable to SRS, including the brain stem, optic apparatus, or eloquent cortex - No primary lesion with radiosensitive histology (e.g., small cell carcinoma, germ cell tumors, lymphoma, leukemia, or multiple myeloma) - No radiographic or cytologic evidence of leptomeningeal disease PATIENT CHARACTERISTICS: - See Disease Characteristics - Not pregnant or nursing - Negative pregnancy test - No concurrent uncontrolled illness including, but not limited to, any of the following: - Symptomatic congestive heart failure - Unstable angina pectoris - Psychiatric illness - No contraindication to SRS, whole-brain radiotherapy, or MRI PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No prior brain surgery other than resection of metastasis - No prior brain radiotherapy


NCT ID:

NCT00811655


Primary Contact:

Principal Investigator
John H. Sampson, MD, PhD
Duke University


Backup Contact:

N/A


Location Contact:

Durham, North Carolina 27710
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.