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A Phase II Trial of Radiosurgery Alone for Brain Metastases in Elderly Patients or Patients With Poor Performance Status


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Cancer

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Trial Information

A Phase II Trial of Radiosurgery Alone for Brain Metastases in Elderly Patients or Patients With Poor Performance Status


OBJECTIVES: I. Determine the efficacy of stereotactic radiosurgery without whole brain
radiotherapy in elderly patients or patients with poor performance status who have brain
metastases. II. Determine the neurologic function in these patients after receiving this
treatment regimen. III. Determine the quality of life in these patients with this treatment
regimen.

OUTLINE: Patients undergo stereotactic head frame placement, followed by stereotactic
radiosurgery using Gamma Knife, on day 1. Quality of life is assessed one week prior to and
one week after treatment, and then at 2, 4, 6, 8, 10, and 12 months. Patients are followed
at one week, at 2, 4, 6, 8, 10, and 12 months, every 4 months for one year, and then every 6
months for 3 years.

PROJECTED ACCRUAL: Approximately 52 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Patients with 1-4 sites of brain metastases Confirmed by MRI with
gadolinium texaphyrin scan within two weeks of study If solitary metastases, diameter must
be 40 mm or less If multiple metastases, one site may be greater than 30 mm, while all
others must be less than 30 mm No metastases in the brainstem or within 5 mm of optic
nerves or chiasm Prior surgical resection of metastases allowed if radiographically
visible residual disease No prior cranial radiotherapy Patients must be over 65 years of
age OR Over 18 years of age with Karnofsky performance status 40-60% All primary
histologies allowed except the following: Lymphomas Leukemia Multiple myeloma Small cell
lung cancer Germ cell tumors Extracranial disease allowed

PATIENT CHARACTERISTICS: Age: See Disease Characteristics Performance status: See Disease
Characteristics Life expectancy: Not specified Hematopoietic: Hemoglobin greater than 8
g/dL Absolute neutrophil count greater than 1,000/mm3 Platelet count greater than
50,000/mm3 Hepatic: Not specified Renal: Not specified

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior chemotherapy
allowed Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Prior
or concurrent radiotherapy to noncranial sites allowed Surgery: See Disease
Characteristics

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Study the effectiveness of stereotactic radiation therapy in treating patients who have brain metastases.

Outcome Time Frame:

Quality of life is assessed one week prior to and one week after treatment, and then at 2, 4, 6, 8, 10, and 12 months. Patients are followed at one week, at 2, 4, 6, 8, 10, and 12 months, every 4 months for one year, and then every 6 months for 3 years.

Safety Issue:

No

Principal Investigator

Donald C. Shina, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CWRU3399

NCT ID:

NCT00006259

Start Date:

January 2000

Completion Date:

February 2005

Related Keywords:

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

Name

Location

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065