Radiation Therapy Following Surgery to Remove Brain Metastases
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|ClinicalTrials.gov Identifier: NCT00003320|
Recruitment Status : Completed
First Posted : February 6, 2004
Last Update Posted : October 30, 2015
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 or disease||Intervention/treatment||Phase|
|Metastatic Cancer||Procedure: surgical procedure Radiation: radiation therapy Radiation: stereotactic radiosurgery||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Official Title:||Pilot Study of Adjuvant Fractionated Stereotactic Radiotherapy Following Surgical Removal of Cerebral Metastases|
|Study Start Date :||March 1997|
|Actual Primary Completion Date :||August 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003320
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1781|
|Study Chair:||Judith M. Ford, MD, PhD||Jonsson Comprehensive Cancer Center|