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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

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.

Condition or disease Intervention/treatment Phase
Brain Metastases Procedure: Stereotactic Radiosurgery Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Clinical Relevance of Margins in Frameless Stereotactic Radiosurgery for Intact Brain Metastases: a Randomized Trial of 0 vs 2 mm Margins
Actual Study Start Date : June 10, 2016
Estimated Primary Completion Date : May 10, 2021
Estimated Study Completion Date : May 10, 2026

Arm Intervention/treatment
Active Comparator: Stereotactic Radiosurgery to 2 mm GTV to PTV margins Procedure: Stereotactic Radiosurgery
The SRS dose will depend on the maximum diameter of the gross tumor volume (GTV)

Experimental: Stereotactic Radiosurgery to 0 mm GTV to PTV margins Procedure: Stereotactic Radiosurgery
The SRS dose will depend on the maximum diameter of the gross tumor volume (GTV)




Primary Outcome Measures :
  1. Progression free survival (PFS) rates estimated by the Kaplan-Meier method at 6 months [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Progression free survival (PFS) rates estimated by the Kaplan-Meier method [ Time Frame: 2 years ]
  2. Overall survival rates [ Time Frame: 6 years ]
  3. Rates of radiation necrosis [ Time Frame: 2 years ]
  4. Rates of pseudoprogression [ Time Frame: 2 years ]
  5. Local failure rates [ Time Frame: 2 years ]
  6. 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 ]
  7. 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 ]
  8. Rates of distant intracranial failure [ Time Frame: 2 years ]
  9. Rates of salvage therapy [ Time Frame: 2 years ]
  10. Association between dose and risk of radionecrosis or pseudoprogression [ Time Frame: 2 years ]


Information from the National Library of Medicine

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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:

  • 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).

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): NCT02747303


Contacts
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Contact: Robyn Hseu 773-834-3198 rhseu@radonc.uchicago.edu

Locations
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United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Robyn Hseu       rhseu@radonc.uchicago.edu   
Principal Investigator: Steven J. Chmura, M.D., Ph.D.         
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Steven J. Chmura, M.D., Ph.D. University of Chicago
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT02747303    
Other Study ID Numbers: IRB15-1476
First Posted: April 21, 2016    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020
Keywords provided by University of Chicago:
brain metastases
Stereotactic Radiosurgery
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
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