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Stereotactic Radiosurgery After Surgery in Treating Patients With Brain Metastases

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ClinicalTrials.gov Identifier: NCT00814463
Recruitment Status : Terminated (Early analysis indicated SRS not as beneficial post-op as pre-op)
First Posted : December 24, 2008
Results First Posted : May 7, 2013
Last Update Posted : February 26, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Duke University

Study Description
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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 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 or disease Intervention/treatment Phase
Metastatic Cancer Unspecified Adult Solid Tumor, Protocol Specific Behavioral: MMSE Behavioral: QOL via FACT-Br Procedure: MRI Radiation: Post-operative SRS Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Single-arm Study of Post-operative Stereotactic Radiosurgery for Brain Metastases.
Study Start Date : August 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Post-operative SRS
All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study.
 Behavioral: MMSE
Neurocognitive function via MMSE done every 3 months for length of study.
Other Name: Mini-Mental Status Exam

Behavioral: QOL via FACT-Br
Quality of Life via FACT-BR every 3 months for length of study.
Other Names:
  • Quality of Life
  • Functional Assessment of Cancer Therapy - Brain

Procedure: MRI
MRI done every 3 months for the length of the study.
Other Name: Magnetic Resonance Imagine

Radiation: Post-operative SRS
Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions.
Other Name: SRS


Outcome Measures
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Primary Outcome Measures :
  1. Recurrence Rate at the Surgical Site as Measured by MRI [ Time Frame: 12 months ]
    The number of months for local recurrence via MRI


Secondary Outcome Measures :
  1. Rate of Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery [ Time Frame: 12 months ]
  2. Rate of New Brain Metastases Outside of the Adjuvant SRS Site [ Time Frame: 12 months ]
  3. Quality of Life as Measured by the FACT-Br Subscales [ Time Frame: Every 3 months for 12 months ]
  4. Preservation of Neurocognitive Function as Measured by the Mini-Mental State Exam [ Time Frame: Every 3 months for 12 months. ]
  5. Clinical Significance (if Any) of Locally Recurrent Brain Metastasis at the Time of Their Occurrence (Mass Effect, Cognitive Functioning, and Other Symptoms) [ Time Frame: 12 months ]
  6. Rate of Death Due to Neurologic Causes [ Time Frame: 12 months ]
  7. Overall Survival [ Time Frame: 12 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00814463


Locations
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United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: John H. Sampson, MD, PhD Duke University
Principal Investigator: Hamidreza Aliabadi, MD Duke University
Principal Investigator: John P. Kirkpatrick, MD Duke University
Principal Investigator: James E. Herndon, PhD Duke University
More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00814463    
Other Study ID Numbers: Pro00004373
DUMC-PRO00004373 ( Other Identifier: DUHS IRB )
CDR0000630239
First Posted: December 24, 2008    Key Record Dates
Results First Posted: May 7, 2013
Last Update Posted: February 26, 2019
Last Verified: February 2019
Keywords provided by Duke University:
tumors metastatic to brain
unspecified adult solid tumor, protocol specific
Additional relevant MeSH terms:
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Brain Neoplasms
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
 Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases