Radiation Therapy Following Surgery to Remove Brain Metastases

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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Pilot Study of Adjuvant Fractionated Stereotactic Radiotherapy Following Surgical Removal of Cerebral Metastases

Conditions
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Metastatic Cancer

Intervention / Treatment
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* Procedure: surgical procedure
* Radiation: radiation therapy
* Radiation: stereotactic radiosurgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Age: 18 and over Karnofsky 60-100% Life expectancy: At least 3 months Prior or concurrent required steroids allowed Prior stereotactic radiotherapy of cerebral metastases allowed provided no prior irradiation of current surgical sites Prior surgery of cerebral metastases allowed Exclusion Criteria: severe asthma requiring therapy allergy to iodine or contrast media pregnant concurrent chemotherapy prior whole brain irradiation or focal irradiation to current sites of disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: surgical procedure|nan|
|Radiation: radiation therapy|nan|
|Radiation: stereotactic radiosurgery|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tumors metastatic to brain