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Radiosurgery Dose Reduction for Brain Metastases on Immunotherapy (RADREMI): A Prospective Pilot Study (RADREMI)

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ClinicalTrials.gov Identifier: NCT04047602
Recruitment Status : Recruiting
First Posted : August 7, 2019
Last Update Posted : September 24, 2020
Sponsor:
Information provided by (Responsible Party):
Gordon A Watson, MD/PhD, Indiana University

Brief Summary:
This study will evaluate the rate of radiation necrosis following treatment with immune checkpoint inhibitor (ICI) treatment and radiation therapy in subjects with metastatic brain cancer. Subjects will be treated with the standard of care immunotherapy followed by radiation therapy via stereotactic radiosurgery at a reduced dose.

Condition or disease Intervention/treatment Phase
Brain Tumor Brain Metastases Brain Cancer Radiation: Reduced Dose SRS Not Applicable

Detailed Description:

This is a prospective, single arm, pilot study to determine the symptomatic radiation necrosis rate at 6 months utilizing dose-reduced stereotactic radiosurgery with immunotherapy for subjects with a diagnosis of 1-10 brain metastases from MRI and tissue diagnosis of primary malignancy.

Primary end-point is 6 month symptomatic radiation necrosis, defined as a 6-month rate of clinical symptomatology requiring steroid administration (i.e. Decadron) and/or operative intervention concomitant with advanced and routine brain imaging findings consistent with radiation necrosis. Follow-up MRIs will be fused with the planning scan for this assessment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radiosurgery Dose Reduction for Brain Metastases on Immunotherapy (RADREMI): A Prospective Pilot Study
Actual Study Start Date : August 21, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arm Intervention/treatment
Experimental: Reduced Dose Stereotactic Radiosugery
Subjects will receive one SRS treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 2, 6, 9, and 12 months post SRS treatment
Radiation: Reduced Dose SRS
Subjects will receive SRS treatment at a reduced dose based on the brain tumor size




Primary Outcome Measures :
  1. Symptomatic radiation necrosis rate [ Time Frame: 6 months post SRS ]
    Defined as the rate of clinical symptomatology requiring steroid administration (i.e. Decadron) and/or operative intervention concomitant with advanced and routine brain imaging findings consistent with radiation necrosis


Secondary Outcome Measures :
  1. Local control rate [ Time Frame: 6 months, 12 months post SRS ]
    Defined as the rate of any new, recurrent, or progressing tumor as defined by Response Assessment in Neuro-oncology (RANO) criteria within the planning target volume

  2. Radiographic radiation necrosis rate [ Time Frame: 6 months, 12 months post SRS ]
    Defined as brain imaging findings on magnetic resonance imaging (MRI), magnetic resonance (MR) perfusion, MR Spectroscopy, and/or positron emmission tomography (PET) imaging consistent with radiation necrosis.

  3. Symptomatic radiation necrosis rate [ Time Frame: 12 months post SRS ]
    Defined as the rate of clinical symptomatology requiring steroid administration (i.e. Decadron) and/or operative intervention concomitant with advanced and routine brain imaging findings consistent with radiation necrosis

  4. Gamma Knife local control rate [ Time Frame: 12 months post SRS ]
    Defined as the rate of any new, recurrent, or progressing tumor as defined by RANO criteria within the planning target volume in subjects who receive SRS via gamma knife techniques

  5. Linear accelerator local control rate [ Time Frame: 12 months post SRS ]
    Defined as the rate of any new, recurrent, or progressing tumor as defined by RANO criteria within the planning target volume in subjects who receive SRS via linear accelerator techniques

  6. Multi agent immune checkpoint inhibitor local control rate [ Time Frame: 12 months post SRS ]
    Defined as the rate of any new, recurrent, or progressing tumor as defined by RANO criteria within the planning target volume in subjects who are treated with multi-agent immune checkpoint inhibitor therapy.

  7. Single agent immune checkpoint inhibitor local control rate [ Time Frame: 12 months post SRS ]
    Defined as the rate of any new, recurrent, or progressing tumor as defined by RANO criteria within the planning target volume in subjects who are treated with single agent immune checkpoint inhibitor therapy.

  8. Melanoma brain metastases local control rate [ Time Frame: 12 months post SRS ]
    Defined as the rate of any new, recurrent, or progressing tumor as defined by RANO criteria within the planning target volume in subjects with metastatic melanoma

  9. Non-melanoma brain metastases local control rate [ Time Frame: 12 months post SRS ]
    Defined as the rate of any new, recurrent, or progressing tumor as defined by RANO criteria within the planning target volume in subjects with non melanoma metastatic disease

  10. Gamma knife symptomatic radiation necrosis rate [ Time Frame: 12 months post SRS ]
    Defined as the rate of clinical symptomatology requiring steroid administration (i.e. Decadron) and/or operative intervention concomitant with advanced and routine brain imaging findings consistent with radiation necrosis in subjects who receive SRS using gamma knife techniques

  11. Linear accelerator symptomatic radiation necrosis rate [ Time Frame: 12 months post SRS ]
    Defined as the rate of clinical symptomatology requiring steroid administration (i.e. Decadron) and/or operative intervention concomitant with advanced and routine brain imaging findings consistent with radiation necrosis in subjects who receive SRS using linear accelerator techniques

  12. Single agent immune checkpoint inhibitor symptomatic radiation necrosis rate [ Time Frame: 12 months post SRS ]
    Defined as the rate of clinical symptomatology requiring steroid administration (i.e. Decadron) and/or operative intervention concomitant with advanced and routine brain imaging findings consistent with radiation necrosis in subjects who are treated with single agent immune checkpoint inhibitor therapy

  13. Multi agent immune checkpoint inhibitor symptomatic radiation necrosis rate [ Time Frame: 12 months post SRS ]
    Defined as the rate of clinical symptomatology requiring steroid administration (i.e. Decadron) and/or operative intervention concomitant with advanced and routine brain imaging findings consistent with radiation necrosis in subjects who are treated with multi agent immune checkpoint inhibitor therapy

  14. Non melanoma brain metastases symptomatic radiation necrosis rate [ Time Frame: 12 months post SRS ]
    Defined as the rate of clinical symptomatology requiring steroid administration (i.e. Decadron) and/or operative intervention concomitant with advanced and routine brain imaging findings consistent with radiation necrosis in subjects with metastatic melanoma

  15. Melanoma brain metastases symptomatic radiation necrosis rate [ Time Frame: 12 months post SRS ]
    Defined as the rate of clinical symptomatology requiring steroid administration (i.e. Decadron) and/or operative intervention concomitant with advanced and routine brain imaging findings consistent with radiation necrosis in subjects with non melanoma metastatic disease



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:

  1. Brain MRI-confirmed 1-10 solid tumor brain metastases
  2. Biopsy-confirmed primary malignancy
  3. Diagnosis-specific graded prognostic assessment (DS-GPA) estimated median survival of at least 6 months
  4. Stereotactic radiosurgery candidate per treating Radiation Oncologist
  5. ≥ 18 years old at the time of informed consent
  6. Ability to provide written informed consent and HIPAA (Health Insurance Portability and Accountability Act) authorization. This will be assessed by the consenting physician using general questions as outlined in Etchells' publication titled Assessment of Patient Capacity to Consent to Treatment
  7. Absolute Lymphocyte Count > 800 units/microliter
  8. Patients currently on cytotoxic chemotherapy are eligible
  9. Patients receiving ICI up to 30 days prior to delivery of SRS

Exclusion Criteria:

  1. Major medical illnesses or psychiatric impairments, which in the investigator's opinion will prevent administration or completion of the protocol therapy and/or interfere with follow-up
  2. Patients unable to receive MRI Brain
  3. Patients with more than 10 brain metastases on MRI Brain imaging
  4. Any lesion > 4 centimeter maximum diameter
  5. Total volume of metastatic disease more than 30 cubic centimeters
  6. Previous whole brain radiation therapy
  7. Previous stereotactic radiosurgery where the 50% isodose line overlaps with current treatment field
  8. Already receiving chronic dexamethasone (chronic = > 2 weeks) prior to SRS
  9. Not a radiosurgical candidate per Radiation Oncology discretion
  10. Existing autoimmune disease
  11. Histology not amenable for SRS (i.e. small cell lung cancer, lymphoma)
  12. Patients who have an unknown primary cancer

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): NCT04047602


Contacts
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Contact: Kathryn Lauer 317-962-3172 KLauer@iuhealth.org
Contact: Amy Miller amym@iu.edu

Locations
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United States, Indiana
Indiana University Health Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Amy Miller       amym@iu.edu   
Sub-Investigator: Shearwood McClelland, MD         
Sub-Investigator: Ryan Rhome, MD,PhD         
Sub-Investigator: Nasser Hanna, MD         
Indiana University Methodist Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Kathryn Lauer    317-962-3172    KLauer@iuhealth.org   
Sub-Investigator: Shearwood McClelland, MD         
Sub-Investigator: Ryan Rhome, MD, PhD         
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Kevin R. Shiue, MD Indiana University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gordon A Watson, MD/PhD, Associate Professor of Clinical Radiation Oncology; Vice Chairman and Medical Director, Indiana University
ClinicalTrials.gov Identifier: NCT04047602    
Other Study ID Numbers: RAON-IIR-IUSCC-0710
First Posted: August 7, 2019    Key Record Dates
Last Update Posted: September 24, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Gordon A Watson, MD/PhD, Indiana University:
Radiation
Immune therapy
Stereotactic Radiosurgery
Additional relevant MeSH terms:
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Neoplasm Metastasis
Brain Neoplasms
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Central Nervous System Diseases
Neoplastic Processes
Pathologic Processes
Brain Diseases
Nervous System Diseases