View Clinical Trial (Medical Research Study)
A Phase II Trial of Focal Therapy in the Treatment of Patients With 1-3 Brain Metastases
| City: |
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Columbus |
| State: |
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Ohio |
| Zip Code: |
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43210 |
| Conditions: |
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Metastatic Cancer - Unspecified Adult Solid Tumor, Protocol Specific |
| Purpose: |
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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
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT00983359 |
| Primary Contact: |
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Principal Investigator
Mario Ammirati, MD
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
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| Backup Contact: |
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N/A |
| Location Contact: |
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Columbus, Ohio 43210
United States
Ohio State University Cancer Clinical Trial Matching Service
Phone: 866-627-7616
Email: osu@emergingmed.com
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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