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Pre-operative Stereotactic Radiosurgery Followed by Resection for Patients With 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: NCT03398694
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Gordon A Watson, MD/PhD, Indiana University

Brief Summary:
This is a prospective, single arm, phase II trial to determine the local control at 6 months utilizing pre-operative stereotactic radiosurgery followed by surgery within 1 - 3 days in subjects with a diagnosis of 1-4 brain metastases and with an indication for surgical resection of at least one brain metastasis at the discretion of a neurosurgeon.

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

Detailed Description:

Primary Objective To evaluate 6 month in-brain local control utilizing pre-operative stereotactic radiosurgery followed by surgical resection for brain metastases.

Secondary Objectives

  • Overall survival
  • Distant in-brain progression
  • Rate of leptomeningeal spread
  • Rate of radiation necrosis

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Analyzing Pre-operative Stereotactic Radiosurgery Followed by Resection for Patients With 1 - 4 Brain Metastases
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : February 28, 2021

Arm Intervention/treatment
Experimental: Arm 1
This is a single arm study so this arm will include all eligible subjects. All subjects will have radiosurgery 1-3 days prior to surgical resection.
Procedure: Radiosurgery
Stereotactic radiosurgery will be delivered on all patients utilizing gamma knife technique based on tumor diameter with the exception that the largest lesion diameter to be treated with 15 Gy will be 5 cm. All apparent, previously untreated brain metastases will be treated with radiosurgery at this time. Radiosurgery will be performed 1-3 days prior to surgical resection.




Primary Outcome Measures :
  1. Rate of local control of any new, recurrent, or progressing tumors within the planning target volume [ Time Frame: 6 months ]
    Measured by post-treatment MRI


Secondary Outcome Measures :
  1. Rate of overall survival [ Time Frame: 6 months, 1 year, and 2 years ]
    Time from start of treatment to death of any cause

  2. Rate of in-brain progression free survival [ Time Frame: 6 months, 1 year, and 2 years ]
    Time from start of treatment to any in-brain

  3. Proportion of patients with distant in-brain failure (any new parenchymal lesion outside of the planning target volume) [ Time Frame: 2 years ]
    Measured by post-treatment MRI

  4. Proportion of patients with radiation necrosis (radiographic or biopsy-positive diagnosis of radiation necrosis) [ Time Frame: 2 years ]
    Measured by post-treatment MRI

  5. Proportion of patients with leptomeningeal spread (radiographic or CSF diagnosis of leptomeningeal disease) [ Time Frame: 2 years ]
    Measured by post-treatment MRI



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. Radiographically confirmed solid tumor brain metastases
  2. Criteria for surgical resection of at least one metastasis per neurosurgeon discretion
  3. A diagnostic MRI Brain or CT Head demonstrating the presence of 1-4 solid tumor brain metastases and lesion to be resected no more than 5 cm in any direction, performed within 30 days prior to stereotactic radiosurgery. If multiple lesions are present, then the total brain metastases volume can be no more than 30 cm3 excluding the lesion to be resected.
  4. For known primary, ds-GPA estimated median survival no less than 6 months
  5. For unknown primary, GPA estimated median survival no less than 6 months
  6. Surgical candidate per neurosurgeon discretion
  7. Surgical resection able to be performed within 1 - 3 days after radiosurgery
  8. Stereotactic radiosurgery candidate per radiation oncologist
  9. ≥ 18 years old at the time of informed consent
  10. Ability to provide written informed consent and HIPAA authorization
  11. Platelet count > 100 k/cumm, Hgb > 7.5 gm/dL, INR < 1.3, ANC > 1.5 k/cumm
  12. Patients currently on cytotoxic chemotherapy or immunotherapy are eligible, not including anti-VEGF therapy

Exclusion Criteria

  1. Patients who received anti-VEGF therapy within 6 weeks prior to enrollment, as there is increased risk of fatal brain hemorrhage with surgical resection
  2. 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
  3. Patients with more than 4 brain metastases on MRI Brain or CT Head
  4. Lesion to be resected is more than 5 cm
  5. Total volume of metastatic disease more than 30 cm3 excluding lesion to be resected
  6. Patients with leptomeningeal metastases documented by MRI or CSF evaluation
  7. Previous whole brain radiation therapy
  8. Previous radiation therapy to lesion to be resected
  9. Planned adjuvant focal therapy including additional radiation therapy to the brain
  10. Not a surgical candidate per neurosurgeon's discretion
  11. Not a radiosurgical candidate per radiation oncologist's discretion
  12. Surgery unable to be performed between 1 - 3 days after radiosurgery
  13. Women who are pregnant or nursing are not eligible as treatment involves unforeseeable risks to the fetus or child
  14. Patients who have a known primary and have an estimated median survival less than 6 months per ds-GPA
  15. Patients who have an unknown primary and have an estimated median survival less than 6 months per GPA

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): NCT03398694


Contacts
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Contact: Amy Miller 317-278-7614 amym@iu.edu

Locations
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United States, Indiana
Indiana University Health Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Amy Miller    317-278-7614    amym@iu.edu   
Principal Investigator: Gordon A. Watson, MD, PhD         
Indiana University Health Methodist Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Kathy Lauer    317-962-3172    klauer@iuhealth.org   
Principal Investigator: Gordon A. Watson, MD, PhD         
Indiana University Melvin and Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Amy Miller    317-278-7614    amym@iu.edu   
Principal Investigator: Gordon A. Watson, MD, PhD         
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Gordon A. Watson, MD, PhD Indiana University School of Medicine

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, Indiana University
ClinicalTrials.gov Identifier: NCT03398694    
Other Study ID Numbers: IUSCC-0627
1707314702 ( Other Identifier: Indiana University IRB )
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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