RATIONALE: Stereotactic radiation therapy may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: Phase II trial to study the effectiveness of stereotactic radiation therapy in treating patients who have brain metastases.

Condition	Treatment or Intervention	Phase
brain metastases	Procedure: Stereotactic radiation therapy	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the efficacy of stereotactic radiosurgery without whole brain radiotherapy in elderly patients or patients with poor performance status who have brain metastases. II. Determine the neurologic function in these patients after receiving this treatment regimen. III. Determine the quality of life in these patients with this treatment regimen.

PROTOCOL OUTLINE: Patients undergo stereotactic head frame placement, followed by stereotactic radiosurgery using Gamma Knife, on day 1. Quality of life is assessed one week prior to and one week after treatment, and then at 2, 4, 6, 8, 10, and 12 months. Patients are followed at one week, at 2, 4, 6, 8, 10, and 12 months, every 4 months for one year, and then every 6 months for 3 years.

PROJECTED ACCRUAL: Approximately 52 patients will be accrued for this study within 2 years.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Patients with 1-4 sites of brain metastases; Confirmed by MRI with gadolinium texaphyrin scan within two weeks of study; If solitary metastases, diameter must be 40 mm or less; If multiple metastases, one site may be greater than 30 mm, while all others must be less than 30 mm; No metastases in the brainstem or within 5 mm of optic nerves or chiasm
• Prior surgical resection of metastases allowed if radiographically visible residual disease
• No prior cranial radiotherapy
• Patients must be over 65 years of age OR Over 18 years of age with Karnofsky performance status 40-60%
• All primary histologies allowed except the following: Lymphomas; Leukemia; Multiple myeloma; Small cell lung cancer; Germ cell tumors
• Extracranial disease allowed

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: Prior chemotherapy allowed
• Endocrine therapy: Not specified
• Radiotherapy: See Disease Characteristics; Prior or concurrent radiotherapy to noncranial sites allowed
• Surgery: See Disease Characteristics

--Patient Characteristics--

• Age: See Disease Characteristics
• Performance status: See Disease Characteristics
• Life expectancy: Not specified
• Hematopoietic: Hemoglobin greater than 8 g/dL; Absolute neutrophil count greater than 1,000/mm3; Platelet count greater than 50,000/mm3
• Hepatic: Not specified
• Renal: Not specified

Ohio
      Ireland Cancer Center, Cleveland,  Ohio,  44106-5065,  United States

Study chairs or principal investigators

Donald C. Shina,  Study Chair,  Ireland Cancer Center   

Study ID Numbers:  CDR0000068193; CWRU-3399; NCI-G00-1853
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  September 11, 2000
ClinicalTrials.gov Identifier:  NCT00006259
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08