Radiation Therapy With or Without Surgery in Treating Patients Who Have Brain Metastases



Status:Completed
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:December 1997

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Prognostic Factors Associated With Successful Omission of Whole Brain Radiotherapy in Patients With 4 or Less Cerebral Metastases Treated With Focal Radiation or Surgery

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.

OBJECTIVES:

- 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.

Inclusion Criteria:

- 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

- Refused whole brain radiation therapy OR

- Received prior whole brain radiation therapy and ineligible for other relapse
protocols

- 18 and over

- Karnofsky 60-100%

- Life expectancy:At least 3 months

- Concurrent steroids allowed

Exclusion Criteria:

- more than four cerebral metastases on MRI scan and suitable for focal treatment with
surgery and/or stereotactic radiotherapy with a linear accelerator

- more than 2 weeks since prior focal radiation

- more than 2 weeks since prior focal surgery
We found this trial at
1
site
10833 Le Conte Avenue # 8-950
Los Angeles, California 90095
(310) 825-5268
Jonsson Comprehensive Cancer Center at UCLA In the late 1960s, a group of scientists and...
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mi
from
Los Angeles, CA
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