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Frameless Stereotactic Radiosurgery for Intact Brain Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02747303
Recruitment Status : Recruiting
First Posted : April 21, 2016
Last Update Posted : April 29, 2020
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Tracking Information
First Submitted Date  ICMJE April 19, 2016
First Posted Date  ICMJE April 21, 2016
Last Update Posted Date April 29, 2020
Actual Study Start Date  ICMJE June 10, 2016
Estimated Primary Completion Date May 10, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2016)
Progression free survival (PFS) rates estimated by the Kaplan-Meier method at 6 months [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2018)
  • Progression free survival (PFS) rates estimated by the Kaplan-Meier method [ Time Frame: 2 years ]
  • Overall survival rates [ Time Frame: 6 years ]
  • Rates of radiation necrosis [ Time Frame: 2 years ]
  • Rates of pseudoprogression [ Time Frame: 2 years ]
  • Local failure rates [ Time Frame: 2 years ]
  • Rate of acute central nervous system (CNS) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grade 2 and higher toxicities [ Time Frame: 90 days ]
  • Rate of late central nervous system (CNS) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grade 2 and higher toxicities [ Time Frame: 6 years ]
  • Rates of distant intracranial failure [ Time Frame: 2 years ]
  • Rates of salvage therapy [ Time Frame: 2 years ]
  • Association between dose and risk of radionecrosis or pseudoprogression [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2016)
Progression free survival (PFS) rates estimated by the Kaplan-Meier method at 1 and 2 years [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Frameless Stereotactic Radiosurgery for Intact Brain Metastases
Official Title  ICMJE The Clinical Relevance of Margins in Frameless Stereotactic Radiosurgery for Intact Brain Metastases: a Randomized Trial of 0 vs 2 mm Margins
Brief Summary This is a randomized study to determine if not treating planning target volume (PTV) margins during radiation therapy worsens progression free survival rates in patients with brain metastases.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Brain Metastases
Intervention  ICMJE Procedure: Stereotactic Radiosurgery
The SRS dose will depend on the maximum diameter of the gross tumor volume (GTV)
Study Arms  ICMJE
  • Active Comparator: Stereotactic Radiosurgery to 2 mm GTV to PTV margins
    Intervention: Procedure: Stereotactic Radiosurgery
  • Experimental: Stereotactic Radiosurgery to 0 mm GTV to PTV margins
    Intervention: Procedure: Stereotactic Radiosurgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 19, 2016)
166
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 10, 2026
Estimated Primary Completion Date May 10, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult patients (≥ 18 years old) with an ECOG Performance Status 0-2 and a life expectancy of 3 months or more.
  • Histologically confirmed systemic malignancy with gadolinium contrast-enhanced MRI scan demonstrating 1-5 intraparenchymal brain metastases.
  • Well-circumscribed, measureable intraparenchymal brain lesion(s) with maximum tumor diameter ≤3.0 cm. If multiple lesions are present, the other(s) must not exceed 3.0 cm in maximum diameter. At least one lesion must be ≥1.0 cm in maximum diameter and ≥0.5 cm in a perpendicular diameter to be considered measurable disease.
  • Negative urine or serum pregnancy test done ≤ 14 days prior to CT simulation, for women of child-bearing potential only.
  • Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

  • Diagnosis of germ cell tumor, small cell carcinoma or hematologic malignancy.
  • Metastases in the brain stem, midbrain, pons, medulla, or within 7 mm of the optic apparatus (optic nerves, chiasm and optic tracts).
  • Diagnosis of leptomeningeal disease.
  • Prior cranial radiotherapy within 90 days of trial enrollment or prior SRS at any time to any lesion to be treated on protocol
  • Chemotherapy (including oral agents and targeted agents) or immunotherapy given within 14 days of SRS. Hormonal therapy is permitted. For Her2+ breast cancer patients, anti-Her2 therapy cannot be given within 14 days of SRS. Patients who are scheduled to receive trastuzumab emtansine after SRS cannot be enrolled.
  • Contraindications to gadolinium contrast-enhanced MRI (eg, non-compatible pacemaker, eGFR<30, gadolinium allergy).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Robyn Hseu 773-834-3198 rhseu@radonc.uchicago.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02747303
Other Study ID Numbers  ICMJE IRB15-1476
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Chicago
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Steven J. Chmura, M.D., Ph.D. University of Chicago
PRS Account University of Chicago
Verification Date April 2020

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