Stereotactic Radiation Therapy in Treating Patients With Brain Metastases



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:April 2007

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

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

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.

DISEASE CHARACTERISTICS:

- Histologically confirmed cancer

- Has 1-3 brain metastases, as evidenced by MRI/CT scan within the past 28 days,
that are clinically symptomatic (any signs and/or symptoms are related to the
metastases) or neurologically symptomatic (mass effect and/or brain shift)

- No primary CNS cancer

- No radiosensitive primary tumors, including any of the following:

- Small cell lung cancer

- Germ cell tumors

- Lymphoma

- Leukemia

- Multiple myeloma

PATIENT CHARACTERISTICS:

- Karnofsky performance status 60-100%

PRIOR CONCURRENT THERAPY:

- No prior whole brain radiotherapy or focal radiotherapy to the metastases considered
for this study

- Prior surgery to remove the tumor allowed provided it was completed within the past
28 days
We found this trial at
1
site
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University...
?
mi
from
Columbus, OH
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