Stereotactic Radiosurgery After Surgery 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:	NCT00814463

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 after surgery may kill any tumor cells that remain after surgery.

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: adjuvant therapy Procedure: cognitive assessment Procedure: quality-of-life assessment Procedure: stereotactic radiosurgery	Phase II

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Phase II Single-Arm Study of Post-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 as measured by MRI [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rate of salvage whole-brain radiotherapy, stereotactic radiosurgery (SRS), or surgery [ Designated as safety issue: No ]
Rate of new brain metastases outside of the adjuvant 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 function as measured by the Mini-Mental State Exam [ Designated as safety issue: No ]
Clinical significance (if any) of locally recurrent brain metastasis at the time of their occurrence (mass effect, cognitive functioning, and other symptoms) [ 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:	August 2008
Estimated Primary Completion Date:	October 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 adjuvant stereotactic radiosurgery (SRS) compared with historical data documenting recurrence at the surgical site after surgery and whole brain radiotherapy (WBRT).

Secondary

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

OUTLINE: Patients undergo stereotactic radiosurgery over 30-90 minutes.

Quality of life and neurocognitive function are assessed periodically.

After completion of study therapy, 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 metastasis from an extracranial primary site
Has undergone gross total resection (as verified by the lack of any enhancement in the resection cavity on post-operative MRI) of a single metastasis confirmed by histology
- Up to 4 metastases are allowed provided the largest mass is amenable to surgical resection and all non-resected masses are amenable to stereotactic radiosurgery (SRS)
- No incomplete or partial resection of the tumor
- No resection cavity > 4 cm in maximal extent in any plane on contrast MRI
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 and optic apparatus
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
Life expectancy ≥ 3 months
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No concurrent uncontrolled illness including, but not limited to, 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: NCT00814463

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:	CDR0000630239, DUMC-PRO00004373
Study First Received:	December 23, 2008
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00814463
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 15, 2009