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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


N/A
18 Years
N/A
Not Enrolling
Both
Metastatic Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Judith M. Ford, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066275

NCT ID:

NCT00003324

Start Date:

December 1997

Completion Date:

Related Keywords:

  • Metastatic Cancer
  • tumors metastatic to brain
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781