RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy after surgery to remove brain metastases may decrease the amount of radiation required to treat brain metastases. PURPOSE: Pilot trial to study the effectiveness of radiation therapy following surgery to remove brain metastases.

Condition	Treatment or Intervention
Brain Neoplasms Metastasis	Procedure: surgery  Procedure: radiation therapy  Procedure: stereotactic radiosurgery

Further Study Details: 

OBJECTIVES: I. Assess the safety and tolerability of focal stereotactic radiotherapy to the surgical bed following excision of cerebral metastases, as an alternative to whole brain irradiation. II. Measure the local relapse rate at the surgical site after surgery and stereotactic radiotherapy in patients with cerebral metastases. III. Measure the regional relapse rate, in the brain but away from the treated site, following treatment in these patients.

PROTOCOL OUTLINE: All patients undergo surgical removal of their cerebral metastases followed by adjuvant fractionated stereotactic radiotherapy daily for 5 days. Patients are given up to 5 weeks following surgery to recover and reach the required performance status. Radiotherapy must commence within 6 weeks of surgery. Patients are followed at 2 weeks after treatment, monthly for 6 months, every 3 months for the next 18 months, every 6 months for the next year, and then annually for years 3-5.

PROJECTED ACCRUAL: There will be 20-40 patients accrued into this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed cerebral metastases post surgical resection; No greater than 3 cerebral metastases postresection
• Gross resection at operation as documented in operation note and postoperative MRI
• Patients must have current surgical sites that have not been previously irradiated
• No other indication for whole brain irradiation (i.e., multiple untreated metastases not suitable for single fraction stereotactic radiotherapy, leptomeningeal disease)

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: No concurrent chemotherapy
• Endocrine therapy: Prior or concurrent required steroids allowed
• Radiotherapy: No prior whole brain irradiation or focal irradiation to current sites of disease; Prior stereotactic radiotherapy of cerebral metastases allowed provided no prior irradiation of current surgical sites
• Surgery: Prior surgery of cerebral metastases allowed

--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
• Pulmonary: No severe asthma requiring therapy
• Other: No allergy to iodine or contrast media; Not pregnant

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:  CDR0000066270; UCLA-HSPC-970101503; NCI-G98-1416; UCLA-HSPC-970101502
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003320
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08