Stereotactic Radiosurgery in Treating Patients With Brain Metastases

Duke University

Status and phase

Terminated

Phase 2

Conditions

Metastatic Cancer

Unspecified Adult Solid Tumor, Protocol Specific

Treatments

Radiation: stereotactic radiosurgery

Procedure: therapeutic conventional surgery

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00811655

DUMC-PRO00006870

CDR0000630230 (Other Identifier)

P30CA014236 (U.S. NIH Grant/Contract)

Pro00006870

Details and patient eligibility

About

RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving stereotactic radiosurgery before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well stereotactic radiosurgery works in treating patients with brain metastases.

Full description

OBJECTIVES:

Primary

To estimate the rate of recurrence at the surgical site in patients with brain metastases treated with neoadjuvant stereotactic radiosurgery (SRS) compared with historical data documenting recurrence at the surgical site after surgical resection and whole-brain radiotherapy (WBRT).

Secondary

To estimate the rate of salvage WBRT, SRS, or surgery in patients treated with neoadjuvant SRS alone.
To determine the volume of adjacent normal brain parenchyma irradiated in these patients.
To estimate the rate of new brain metastases outside of the neoadjuvant SRS site in these patients.
To estimate the quality of life of these patients after neoadjuvant SRS alone.
To assess the effect of SRS and surgical intervention on the preservation of neurocognitive functioning in these patients.
To determine the clinical significance (mass effect, cognitive functioning, and other symptoms) of locally recurrent brain metastases at the time of their occurrence in these patients.
To estimate the rate of death due to neurologic causes, defined as death attributable to the progression of neurological disease, in these patients.
To estimate the overall survival of these patients.

OUTLINE: Patients undergo stereotactic radiosurgery over 30 to 90 minutes. Approximately 2-4 weeks later, patients undergo surgical resection of brain metastasis.

Quality of life and neurocognitive function are assessed periodically using the FACT-Br subscales and Mini-Mental State Exam.

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 1 year.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Diagnosis of brain metastases from an extracranial primary site
- Tumor ≤ 4 cm in maximal extent in any plane on contrast MRI
Scheduled to undergo gross total resection of a single brain metastasis confirmed by histology
- Up to 4 metastases allowed provided the largest mass is amenable to surgical resection and all non-resected masses are amenable to stereotactic radiosurgery (SRS)
RTOG Recursive Partitioning Analysis (RPA) class 1 or 2, as defined by the following:
- RPA class 1: Karnofsky performance status (KPS) 70-100%; age < 65 years; controlled primary disease; and no extracranial metastatic disease
- RPA class 2: KPS 70-100%; uncontrolled primary disease; and/or extracranial metastatic disease
No lesion located in anatomic regions that are not amenable to SRS, including the brain stem, optic apparatus, or eloquent cortex
No primary lesion with radiosensitive histology (e.g., small cell carcinoma, germ cell tumors, lymphoma, leukemia, or multiple myeloma)
No radiographic or cytologic evidence of leptomeningeal disease

PATIENT CHARACTERISTICS:

See Disease Characteristics
Not pregnant or nursing
Negative pregnancy test
No concurrent uncontrolled illness including, but not limited to, any of the following:
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Psychiatric illness
No contraindication to SRS, whole-brain radiotherapy, or MRI