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Phase II Single-arm Study of Pre-operative Stereotactic Radiosurgery for Brain Metastases.

Phase 2
18 Years
Not Enrolling
Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase II Single-arm Study of Pre-operative Stereotactic Radiosurgery for Brain Metastases.



- 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).


- 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

- 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.

Inclusion Criteria


- 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

- Up to 4 metastases allowed provided the largest mass is amenable to surgical
resection and all non-resected masses are amenable to stereotactic radiosurgery

- 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


- See Disease Characteristics

- Not pregnant or nursing

- Negative pregnancy test

- No concurrent uncontrolled illness including, but not limited to, any of the

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Psychiatric illness

- No contraindication to SRS, whole-brain radiotherapy, or MRI


- See Disease Characteristics

- No prior brain surgery other than resection of metastasis

- No prior brain radiotherapy

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recurrence rate at the surgical site within 12 months after neoadjuvant stereotactic radiosurgery (SRS) as measured by MRI

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

John H. Sampson, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University


United States: Food and Drug Administration

Study ID:




Start Date:

October 2008

Completion Date:

April 2012

Related Keywords:

  • Metastatic Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • tumors metastatic to brain
  • unspecified adult solid tumor, protocol specific
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



Duke University Medical Center Durham, North Carolina  27710