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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

August 29, 2016
September 1, 2016
November 6, 2017
May 12, 2017
May 2019   (Final data collection date for primary outcome measure)
Proportion of patients who live longer than predicted according to the Graded Prognostic Assessment (GPA) score [ Time Frame: Up to 24 months after SRS ]
Same as current
Complete list of historical versions of study NCT02886572 on ClinicalTrials.gov Archive Site
  • 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
  • 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 ]
  • 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
  • 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 ]
Same as current
Not Provided
Not Provided
 
SIMT Stereotactic Radiosurgery Outcomes Study
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
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

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.

Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Brain Metastases, Adult
Radiation: Stereotactic radiosurgery
Linear-accelerator-based, single-isocenter, image-guided stereotactic radiosurgery
Other Name: SRS
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
Intervention: Radiation: Stereotactic radiosurgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
Same as current
May 2019
May 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Tykeytra Dale, RN MS 919 6683726 tykeytra.dale@dm.duke.edu
Contact: Joan Cahill, RN BNS 919 6683726
United States
 
 
NCT02886572
Pro00075429
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Duke University
Duke University
Varian Medical Systems
Principal Investigator: Grace J. Kim, MD PhD Duke University Medical Center, Radiation Onoclogy
Duke University
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP