Stereotactic Radiation Therapy in Treating Patients With Brain Metastases

The Ohio State University

Status: Completed

Conditions: Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Treatments: Radiation: Radiation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00983359

OSU-06138

NCI-2011-03139 (Registry Identifier)

Details and patient eligibility

About

RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This phase II trial is study how well stereotactic radiation therapy works in treating patients with brain metastases

Full description

OBJECTIVES:

Primary

• To determine the neurological death rate following the initiation of conformal stereotactic radiotherapy in patients with 1-3 brain metastases.

Secondary

• To determine the overall survival rate at 6 months.
• To determine the progression-free survival rate or brain metastases recurrence rate at 6 months.
• To determine the time to neurological death, time to systemic death, and Karnofsky decay time.
• To determine the frequency and severity of adverse events associated with conformal stereotactic radiotherapy.

OUTLINE: Patients undergo conformal stereotactic radiotherapy over 5 days to an area including 3 mm around the metastases or the surgical cavity. Patients may receive additional radiotherapy if symptomatic metastases emerge at different sites.

After completion of study treatment, patients are followed up at 1 and 2 months and then every 3 months thereafter.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histology-confirmed cancer with 1 to 3 symptomatic brain metastases imaged by MRI/CT scans.
• Have cancer not originating in central nervous system (CNS)
• Karnofsky score of at least 60
• Given written consent
• At least 18 years of age

Exclusion criteria

• Prior whole brain radiotherapy or prior focal radiotherapy of the metastasis/es considered for this trial.
• Certain radiosensitive primary tumors such as small cell lung cancer, germ cell tumors, lymphoma, leukemia or multiple myeloma.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Treatment (conformal stereotactic radiation therapy)

Experimental group

Description:

Patients undergo conformal stereotatic radiation

Treatment:

Radiation: Radiation Therapy