Stereotactic Radiosurgery in Treating Patients With Brain Metastases

NCT ID: NCT00811655

Last Updated: 2013-11-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2010-08-31

Brief Summary

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.

Detailed 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.

Conditions

Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

tumors metastatic to brain; unspecified adult solid tumor, protocol specific

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pre-Operative SRS

SRS pre-operatively with the planned target volume defined as the tumor plus a 3-mm margin.

Group Type: EXPERIMENTAL

therapeutic conventional surgery

Intervention Type: PROCEDURE

Surgery of a single brain metastasis.

stereotactic radiosurgery

Intervention Type: RADIATION

Pre-operative single fraction SRS

Interventions

therapeutic conventional surgery

Surgery of a single brain metastasis.

Intervention Type: PROCEDURE

stereotactic radiosurgery

Pre-operative single fraction SRS

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior brain surgery other than resection of metastasis
• No prior brain radiotherapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John H. Sampson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Hamidreza Aliabadi, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

John P. Kirkpatrick, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

James E. Herndon, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

P30CA014236

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DUMC-PRO00006870

Identifier Type: -

Identifier Source: secondary_id

CDR0000630230

Identifier Type: OTHER

Identifier Source: secondary_id

Pro00006870

Identifier Type: -

Identifier Source: org_study_id