Stereotactic Radiosurgery in Treating Patients With Brain Metastases

Phase 2

Terminated

Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Metastatic Cancer

Interventions: Procedure: therapeutic conventional surgery
Radiation: stereotactic radiosurgery

Registration Number: NCT00811655

Lead Sponsor: Duke University

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pre-Operative SRS	therapeutic conventional surgery	SRS pre-operatively with the planned target volume defined as the tumor plus a 3-mm margin.
Pre-Operative SRS	stereotactic radiosurgery	SRS pre-operatively with the planned target volume defined as the tumor plus a 3-mm margin.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Local Recurrence at the Surgical Site Within 12 Months After Stereotactic Radiosurgery (SRS)	Within 12 months after SRS	Number of patients with local recurrence at the surgical site within 12 months after stereotactic radiosurgery (SRS) as measured by magnetic resonance imaging (MRI). To determine local recurrence, we evaluated follow-up MRI's for reappearance of a lesion in exactly the same site in the brain as the first lesion(s).

Secondary Outcome Measures

Name	Time	Method
Volume of Adjacent Normal Brain Parenchyma Irradiated	At time of SRS	Volume of adjacent normal brain parenchyma irradiated during stereotactic radiosurgery (SRS).
Number of Patients With New Brain Metastases Outside of the Pre-operative Stereotactic Radiosurgery (SRS) Site	Within 24 months post-SRS	Number of patients with new brain metastases outside of the pre-operative stereotactic radiosurgery (SRS) site.
Clinical Significance of Locally Recurrent Brain Metastases	24 months post-SRS	Number of patients with clinical significance (mass effect, cognitive functioning, and other symptoms) of locally recurrent brain metastases at the time of their occurrence.
Quality of Life After Stereotactic Radiosurgery (SRS) as Measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br)	Administered at baseline and every 3 months post-SRS	Quality of life as measured by the change in FACT-Br scores from baseline. The FACT-Br (version 4) is comprised of the Functional Assessment of Cancer Therapy-General (FACT-G), a 27-item core questionnaire evaluating the domains of physical, family/social, emotional and functional well-being, with the addition of 23 brain cancer specific questions. The FACT-G total score is the sum of the four FACT-G domain scores. The Brain Cancer Subscale (BrCS) is the sum of 19 brain cancer specific questions. The FACT-Br Trial Outcome Index (TOI) is the sum of the BrCS score and the physical and family/social domain scores. The FACT-Br total score is the sum of the FACT-G total score and the BrCS score. Change score = score post-SRS minus the score at baseline. Positive change scores indicate improved quality of life.
Preservation of Neurocognitive Functioning as Measure by the Mini-Mental State Exam (MMSE)	Administered at baseline and every 3 months post-SRS	Cognition as measured by the change in the Mini-Mental State Exam (MMSE) scores from baseline. The MMSE is an 11-item measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall and language. The maximum score is 30. Change score = score post-SRS minus the score at baseline. Positive change scores indicate improved cognition.
Number of Patients Receiving Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery	Within 24 months post-SRS	Number of patients receiving salvage whole-brain radiotherapy, stereotactic radiosurgery (SRS), or surgery
Number of Patients Who Died Due to Neurological Causes	Within 24 months post-SRS	Number of patients who died due to neurological causes defined as death attributable to the progression of neurological disease.
Overall Survival (OS)	24 months after SRS	Time in months from the date of stereotactic radiosurgery (SRS) to the date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.