Radiation Therapy With or Without Surgery in Treating Patients Who Have Brain Metastases
|ClinicalTrials.gov Identifier: NCT00003324|
Recruitment Status : Completed
First Posted : April 25, 2003
Last Update Posted : October 2, 2015
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 or disease||Intervention/treatment||Phase|
|Metastatic Cancer||Procedure: conventional surgery Radiation: radiation therapy||Not Applicable|
- Develop prognostic factors for patients with brain metastases treated by focal treatment without concurrent whole brain irradiation.
- Determine whether focal treatment without whole brain radiotherapy produces good long-term outcome in patients with four or less cerebral metastases.
- Assess survival, physical and cognitive functioning, and quality of life of patients treated on this 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Official Title:||Prognostic Factors Associated With Successful Omission of Whole Brain Radiotherapy in Patients With 4 or Less Cerebral Metastases Treated With Focal Radiation or Surgery|
|Study Start Date :||December 1997|
|Actual Primary Completion Date :||July 2006|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003324
|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|