A Phase II Trial of Focal Therapy in the Treatment of Patients With 1-3 Brain Metastases
18 Years
N/A
Both
Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
A Phase II Trial of Focal Therapy in the Treatment of Patients With 1-3 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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Neurological death rate
Safety Issue:
No
Principal Investigator
Mario Ammirati, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Ohio State University Comprehensive Cancer Center
Authority:
Unspecified
Study ID:
CDR0000654129
NCT ID:
NCT00983359
Start Date:
April 2007
Completion Date:
Related Keywords:
- Metastatic Cancer
- Unspecified Adult Solid Tumor, Protocol Specific
- tumors metastatic to brain
- unspecified adult solid tumor, protocol specific
- Neoplasm Metastasis
- Neoplasms
- Neoplasms, Second Primary
Name | Location |
|---|---|
| Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus, Ohio 43210-1240 |
