Clinical trial NCT00811655: Stereotactic Radiosurgery in Treating Patients With Brain Metastases
Official title: Phase II Single-arm Study of Pre-operative Stereotactic Radiosurgery for Brain Metastases.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Metastatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: tumors metastatic to brain
unspecified adult solid tumor, protocol specific
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-12-19
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Number of Patients With Local Recurrence at the Surgical Site Within 12 Months After Stereotactic Radiosurgery (SRS)
timeFrame: Within 12 months after SRS
Secondary outcomes:
measure: Number of Patients Receiving Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery
timeFrame: Within 24 months post-SRS
measure: Volume of Adjacent Normal Brain Parenchyma Irradiated
timeFrame: At time of SRS
measure: Number of Patients With New Brain Metastases Outside of the Pre-operative Stereotactic Radiosurgery (SRS) Site
timeFrame: Within 24 months post-SRS
measure: Quality of Life After Stereotactic Radiosurgery (SRS) as Measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br)
timeFrame: Administered at baseline and every 3 months post-SRS
measure: Preservation of Neurocognitive Functioning as Measure by the Mini-Mental State Exam (MMSE)
timeFrame: Administered at baseline and every 3 months post-SRS
measure: Clinical Significance of Locally Recurrent Brain Metastases
timeFrame: 24 months post-SRS
measure: Number of Patients Who Died Due to Neurological Causes
timeFrame: Within 24 months post-SRS
measure: Overall Survival (OS)
timeFrame: 24 months after SRS
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: John H. Sampson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Hamidreza Aliabadi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: John P. Kirkpatrick, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: James E. Herndon, PhD
role: PRINCIPAL_INVESTIGATOR
References: