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SIMT Stereotactic Radiosurgery Outcomes Study (SIMT)

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ClinicalTrials.gov Identifier: NCT02886572
Recruitment Status : Recruiting
First Posted : September 1, 2016
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
Varian Medical Systems
Information provided by (Responsible Party):
Duke University

Study Description
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Brief Summary:
The purpose of this study is to determine the effectiveness and efficiency of Single Isocenter Multi-target Stereotactic Radiosurgery (SIMT SRS) in patients with four or more brain metastases

Condition or disease Intervention/treatment Phase
Brain Metastases, Adult Radiation: Stereotactic radiosurgery Not Applicable

Detailed Description:

Forty patients with four or more brain metastases will be enrolled prior to radiosurgery. A planning MRI brain scan will be performed with GD-DPTA within one week prior to radiosurgery, per the standard of care. Neurocognitive (Mini-Mental Status Examination (MMSE), Trail-making test A&B, Hopkins Learning Verbal (HVLT)) and functional assessment of cancer therapy-brain (FACT- Br) will be obtained prior to radiosurgery. Dose will be prescribed to the maximum isodose line encompassing the resulting PTV using the dose guidelines as described below.

The primary endpoint will be the proportion of patients who live longer than predicted based on the diagnosis-specific GPA score. The Kaplan-Meier estimator will be used to describe the survival of all patients treated with SIMT SRS. Secondary endpoints will be the rate of recurrence at the treated metastases sites, the rate of new brain metastases at a site different from the SRS-treated metastases sites, the rate of death due to neurological causes, and the prevalence of significant adverse events. Exploratory endpoints include change over time in neurocognition and quality of life, quantification of dosimetric measures, the rate of salvage therapy, the rate of radionecrosis at the SRS treatment sites, and the rate and intensity of steroid-usage post-SRS.

All patients will be evaluated for neurocognitive function via MMSE, HVLT, and Trail-making tests A & B, quality of life via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study. These evaluations will be done at regular follow-up evaluations or when local recurrence is suspected on the basis of symptoms. Distant recurrence is defined as the appearance of new brain metastases at a site different from that of the original metastases. Recurrence will further be defined as a new area of enhancement that measures greater than 5 millimeters in the axial plane on MRI. The length of time to recurrence of the original brain metastases will be calculated from the date of the brain metastases radiosurgery to the date that a recurrence was detected by MRI. Patients with suspected recurrent tumor and/or who are symptomatic may undergo a stereotactic biopsy to evaluate for radionecrosis versus recurrent brain metastases, as is standard of care.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outcome in Patients With 4 or More Brain Metastases Treated With Single-Isocenter, Multi-Target (SIMT) Stereotactic Radiosurgery: A Prospective Single-arm Study in Adults With Brain Metastases
Actual Study Start Date : May 12, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Stereotactic Radiosurgery
All subjects will receive stereotactic radiosurgery(SRS) following the RTOG Stereotactic Radiotherapy Guidelines available at http://dx.doi.org/10.1016/j.prro.2011.06.014
 Radiation: Stereotactic radiosurgery
Linear-accelerator-based, single-isocenter, image-guided stereotactic radiosurgery
Other Name: SRS


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients who live longer than predicted according to the Graded Prognostic Assessment (GPA) score [ Time Frame: Up to 24 months after SRS ]

Secondary Outcome Measures :
  1. Proportion of patients that experience local brain recurrence within 1 year of SIMT SRS treatment. [ Time Frame: Up to 12 months after SRS ]
    Serial MRI's

  2. Proportion of patients who are dead within 1 year of SIMT SRS treatment due to neurologic reasons [ Time Frame: Up to 12 months after SRS ]
  3. Proportion of patients that experience a new brain metastasis at a site different from the original brain metastasis site 1 year after SIMT SRS treatment [ Time Frame: Up to 12 months after SRS ]
    Serial MRI's

  4. Proportion of patients who experience grade 3, 4, or 5 neurologic adverse events attributable to SIMT SRS [ Time Frame: Up to 12 months after SRS ]

Eligibility Criteria
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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. A contrast-enhanced MRI scan showing = or > 4 brain metastases.
  2. Age >/=18 years of age.
  3. KPS >/= 70
  4. Patient must have a graded prosnostic score (GPA) score 0.5 or greater
  5. Life expectancy of at least 3 months
  6. Postoperative patients with resected brain metastases are eligible.
  7. Largest lesion < 4cm diameter
  8. Must be a candidate for MRI imaging
  9. Previous cranial stereotactic radiosurgery (SRS) or whole brain radiation therapy (WBRT) is allowed if > 3 months prior to SIMT
  10. Must be capable of providing informed consent

Exclusion Criteria:

  1. Primary lesion with radiosensitive histology (i.e., small cell carcinoma, germ-cell tumors, lymphoma, leukemia, and multiple myeloma).
  2. Metastases within 2 mm of the optic apparatus
  3. Patients unable to obtain MRI
  4. Evidence of leptomeningeal disease
  5. Greater than 10 brain metastases
  6. Pregnant women are excluded
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): NCT02886572


Contacts
Contact: Tykeytra Dale, RN MS 919 6683726 tykeytra.dale@dm.duke.edu
Contact: Joan Cahill, RN BNS 919 6683726

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Joan Cahill, RN BNS    919-668-3726      
Contact: Tykeytra Dale, RN MS    919 6683726      
Sponsors and Collaborators
Duke University
Varian Medical Systems
Investigators
Principal Investigator: Grace J. Kim, MD PhD Duke University Medical Center, Radiation Onoclogy
More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02886572     History of Changes
Other Study ID Numbers: Pro00075429
First Posted: September 1, 2016    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neoplasm Metastasis
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
 Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases