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



- 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).


- 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.

Inclusion Criteria:

1. Age >18 years of age.

2. Gross total resection (as verified by the lack of any enhancement in the resection
cavity on post-operative MRI) of single brain metastasis confirmed by histology.
Patients with up to 4 metastases are eligible if the largest mass is amenable to
surgical resection and all non-resected masses are amenable to SRS.

3. Patient must be Radiation Therapy Oncology Group (RTOG) recursive partitioning
analysis (RPA) Class 1 or 2.

4. Life expectancy of at least 3 months.

Exclusion Criteria:

1. Radiographic or cytologic evidence of leptomeningeal disease.

2. Patient with incomplete or partial resection.

3. Primary lesion with radiosensitive histology (i.e., small cell carcinoma, germ-cell
tumors, lymphoma, leukemia, and multiple myeloma).

4. Patients with a resection cavity > 4 cm in maximal extent in any plane on contrasted
MRI scan.

5. Lesion located in anatomic regions which are not amenable to SRS including the brain
stem and optic apparatus.

6. Pregnant or need to breast feed during the study period.

7. Uncontrolled intercurrent illness including, but not limited to symptomatic
congestive heart failure, unstable angina pectoris, or psychiatric illness.

8. Brain surgery other than for resection of metastasis.

9. Previous brain radiotherapy.

10. Contraindication to SRS, WBRT, or MRI.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recurrence Rate at the Surgical Site as Measured by MRI

Outcome Description:

The number of months for local recurrence via 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: Institutional Review Board

Study ID:

Pro00004373 (CDR0000630239)



Start Date:

August 2008

Completion Date:

June 2009

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 Comprehensive Cancer Center Durham, North Carolina  27710