Stereotactic Radiosurgery in Treating Patients With Brain Metastases

This study has been terminated.
(Slow recruitment)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00811655
First received: December 18, 2008
Last updated: October 30, 2013
Last verified: October 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 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.


Condition Intervention Phase
Metastatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Procedure: therapeutic conventional surgery
Radiation: stereotactic radiosurgery
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Number of Patients With Local Recurrence at the Surgical Site Within 12 Months After Stereotactic Radiosurgery (SRS) [ Time Frame: Within 12 months after SRS ] [ Designated as safety issue: No ]
    Number of patients with local recurrence at the surgical site within 12 months after stereotactic radiosurgery (SRS) as measured by magnetic resonance imaging (MRI). To determine local recurrence, we evaluated follow-up MRI's for reappearance of a lesion in exactly the same site in the brain as the first lesion(s).


Secondary Outcome Measures:
  • Number of Patients Receiving Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery [ Time Frame: Within 24 months post-SRS ] [ Designated as safety issue: No ]
    Number of patients receiving salvage whole-brain radiotherapy, stereotactic radiosurgery (SRS), or surgery

  • Volume of Adjacent Normal Brain Parenchyma Irradiated [ Time Frame: At time of SRS ] [ Designated as safety issue: No ]
    Volume of adjacent normal brain parenchyma irradiated during stereotactic radiosurgery (SRS).

  • Number of Patients With New Brain Metastases Outside of the Pre-operative Stereotactic Radiosurgery (SRS) Site [ Time Frame: Within 24 months post-SRS ] [ Designated as safety issue: No ]
    Number of patients with new brain metastases outside of the pre-operative stereotactic radiosurgery (SRS) site.

  • Quality of Life After Stereotactic Radiosurgery (SRS) as Measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br) [ Time Frame: Administered at baseline and every 3 months post-SRS ] [ Designated as safety issue: No ]
    Quality of life as measured by the change in FACT-Br scores from baseline. The FACT-Br (version 4) is comprised of the Functional Assessment of Cancer Therapy-General (FACT-G), a 27-item core questionnaire evaluating the domains of physical, family/social, emotional and functional well-being, with the addition of 23 brain cancer specific questions. The FACT-G total score is the sum of the four FACT-G domain scores. The Brain Cancer Subscale (BrCS) is the sum of 19 brain cancer specific questions. The FACT-Br Trial Outcome Index (TOI) is the sum of the BrCS score and the physical and family/social domain scores. The FACT-Br total score is the sum of the FACT-G total score and the BrCS score. Change score = score post-SRS minus the score at baseline. Positive change scores indicate improved quality of life.

  • Preservation of Neurocognitive Functioning as Measure by the Mini-Mental State Exam (MMSE) [ Time Frame: Administered at baseline and every 3 months post-SRS ] [ Designated as safety issue: No ]
    Cognition as measured by the change in the Mini-Mental State Exam (MMSE) scores from baseline. The MMSE is an 11-item measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall and language. The maximum score is 30. Change score = score post-SRS minus the score at baseline. Positive change scores indicate improved cognition.

  • Clinical Significance of Locally Recurrent Brain Metastases [ Time Frame: 24 months post-SRS ] [ Designated as safety issue: No ]
    Number of patients with clinical significance (mass effect, cognitive functioning, and other symptoms) of locally recurrent brain metastases at the time of their occurrence.

  • Number of Patients Who Died Due to Neurological Causes [ Time Frame: Within 24 months post-SRS ] [ Designated as safety issue: Yes ]
    Number of patients who died due to neurological causes defined as death attributable to the progression of neurological disease.

  • Overall Survival (OS) [ Time Frame: 24 months after SRS ] [ Designated as safety issue: No ]
    Time in months from the date of stereotactic radiosurgery (SRS) to the date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.


Enrollment: 6
Study Start Date: October 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pre-Operative SRS
SRS pre-operatively with the planned target volume defined as the tumor plus a 3-mm margin.
Procedure: therapeutic conventional surgery
Surgery of a single brain metastasis.
Radiation: stereotactic radiosurgery
Pre-operative single fraction SRS

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00811655

Locations
United States, North Carolina
Duke University Medical 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: NCT00811655     History of Changes
Other Study ID Numbers: Pro00006870, P30CA014236, DUMC-PRO00006870, CDR0000630230
Study First Received: December 18, 2008
Results First Received: August 15, 2013
Last Updated: October 30, 2013
Health Authority: United States: Food and Drug Administration

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 August 01, 2014