Stereotactic Radiosurgery in Treating Patients With Brain Metastases - Full Text View

Sponsors and Collaborators:	Duke University National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00811655

Purpose

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.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors Unspecified Adult Solid Tumor, Protocol Specific	Procedure: cognitive assessment Procedure: neoadjuvant therapy Procedure: quality-of-life assessment Procedure: stereotactic radiosurgery Procedure: therapeutic conventional surgery	Phase II

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Phase II Single-Arm Study of Pre-Operative Stereotactic Radiosurgery for Brain Metastases.

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Recurrence rate at the surgical site within 12 months after neoadjuvant stereotactic radiosurgery (SRS) as measured by MRI [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rate of salvage whole-brain radiotherapy, SRS, or surgery [ Designated as safety issue: No ]
Volume of adjacent normal brain parenchyma irradiated [ Designated as safety issue: No ]
Rate of new brain metastases outside of the neoadjuvant SRS site [ Designated as safety issue: No ]
Quality of life as measured by the FACT-Br subscales [ Designated as safety issue: No ]
Preservation of neurocognitive functioning as measured by the Mini-Mental State Exam [ Designated as safety issue: No ]
Clinical significance (mass effect, cognitive functioning, and other symptoms) of locally recurrent brain metastases at the time of their occurrence [ Designated as safety issue: No ]
Rate of death due to neurologic causes [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]

Estimated Enrollment:	25
Study Start Date:	October 2008
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811655

Locations

United States, North Carolina
Duke Comprehensive Cancer Center	Recruiting
Durham, North Carolina, United States, 27710
Contact: Clinical Trials Office - Duke Comprehensive Cancer Center 888-275-3853

Sponsors and Collaborators

Duke University

National Cancer Institute (NCI)

Investigators

Principal Investigator:	John H. Sampson, MD, PhD	Duke University
Investigator:	Hamidreza Aliabadi, MD	Duke University
Investigator:	John P. Kirkpatrick, MD	Duke University
Investigator:	James E. Herndon, PhD	Duke University

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Responsible Party:	Duke University Medical Center ( John H. Sampson )
Study ID Numbers:	CDR0000630230, DUMC-PRO00006870
Study First Received:	December 18, 2008
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00811655
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Neoplasm Metastasis
Central Nervous System Neoplasms
Nervous System Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009