RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells in a single high dose. Combining radiation therapy with surgery may be a more effective treatment for brain metastases. PURPOSE: Clinical trial to study the effectiveness of radiation therapy with or without surgery in treating patients who have brain metastases.

Condition	Treatment or Intervention
brain metastases	Procedure: surgery  Procedure: radiation therapy  Procedure: conventional surgery

Further Study Details: 

OBJECTIVES: I. Develop prognostic factors for patients with brain metastases treated by focal treatment without concurrent whole brain irradiation. II. Determine whether focal treatment without whole brain radiotherapy produces good long-term outcome in patients with four or less cerebral metastases. III. Assess survival, physical and cognitive functioning, and quality of life of patients treated on this protocol.

PROTOCOL OUTLINE: Quality of life is assessed using the FACT-BR scale, physical function is assessed using the FIM scale, and cognition is assessed using two brief pencil and paper tests. Patients receive focal therapy for cerebral metastases by any combination of (1) surgery plus fractionated stereotactic radiotherapy to surgical bed, or (2) single fraction stereotactic radiotherapy by linear accelerator with or without a radiation sensitizer. Patients are followed at 2 and 10 weeks, then every 3 months for 18 months, then every 6 months for 3 years, then annually. Quality of life is assessed at each followup visit. Patients suffering intracerebral relapse are offered further focal therapy if they have no more than 3 metastases, no more than 6 lesions over consecutive scans, and continue to have life expectancy of at least 3 months and Karnofsky performance status of 60-100%. Otherwise, relapsed patients are offered whole brain radiotherapy or supportive treatment with steroids, and may also receive stereotactic boost to the new lesions. Patients who have received prior whole brain irradiation will be offered entry into other protocols if eligible or supportive treatment with steroids. Patients are followed as above.

PROJECTED ACCRUAL: At least 60 patients will be enrolled in this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Biopsy, CT scan, or MRI proven cerebral metastases with known current or previous systemic malignancy OR Biopsy proven cerebral metastases other than from small cell lung cancer or lymphoma
• No more than four cerebral metastases on MRI scan and suitable for focal treatment with surgery and/or stereotactic radiotherapy with a linear accelerator
• Refused whole brain radiation therapy OR Received prior whole brain radiation therapy and ineligible for other relapse protocols

--Prior/Concurrent Therapy--

Biologic therapy: Not specified

Chemotherapy: Not specified

Endocrine therapy: Concurrent steroids allowed

Radiotherapy:

• No more than 2 weeks since prior focal radiation
• See Disease Characteristics

Surgery: No more than 2 weeks since prior focal surgery

--Patient Characteristics--

Age: 18 and over

Performance status: Karnofsky 60-100%

Life expectancy: At least 3 months

Hematopoietic: Not specified

Hepatic: Not specified

Renal: Not specified

California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States

Study chairs or principal investigators

Judith M. Ford,  Study Chair,  Jonsson Comprehensive Cancer Center   

Study ID Numbers:  CDR0000066275; UCLA-HSPC-9710074; NCI-G98-1417; UCLA-HSPC-971007401
Record last reviewed:  April 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003324
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08