Stereotactic Radiosurgery After Surgery in Treating Patients With Brain Metastases

This study has been terminated.
(Early analysis indicated SRS not as beneficial post-op as pre-op)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00814463
First received: December 23, 2008
Last updated: July 9, 2014
Last verified: May 2013
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Single-arm Study of Post-operative Stereotactic Radiosurgery for Brain Metastases.

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Recurrence Rate at the Surgical Site as Measured by MRI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The number of months for local recurrence via MRI


Secondary Outcome Measures:
  • Rate of Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Rate of New Brain Metastases Outside of the Adjuvant SRS Site [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of Life as Measured by the FACT-Br Subscales [ Time Frame: Every 3 months for 12 months ] [ Designated as safety issue: No ]
  • Preservation of Neurocognitive Function as Measured by the Mini-Mental State Exam [ Time Frame: Every 3 months for 12 months. ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Rate of Death Due to Neurologic Causes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: August 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00814463

Locations
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00814463     History of Changes
Other Study ID Numbers: Pro00004373, DUMC-PRO00004373, CDR0000630239
Study First Received: December 23, 2008
Results First Received: January 23, 2013
Last Updated: July 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
tumors metastatic to brain
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014