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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

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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 CenterColumbus, Ohio  43210-1240