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Pre-operative Stereotactic Radiosurgery Followed by Resection for Patients With Brain Metastases

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ClinicalTrials.gov Identifier: NCT03398694
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : June 4, 2021
Sponsor:
Information provided by (Responsible Party):
Namita Agrawal, 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 - 4 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 Not Applicable

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 : 50 participants
Allocation: N/A
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 : March 31, 2022
Estimated Study Completion Date : September 30, 2022

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 1-4 days prior to surgical resection.
Procedure: Radiosurgery

Stereotactic radiosurgery will be delivered on all patients utilizing gamma knife or linear accelerator based techniques as per RTOG-9005 dosing criteria (Section 11 Table 1) 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 1-4 days prior to surgical resection. Vital signs and MRI Brain planning scan will be performed on the day of radiosurgery prior to the procedure.





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


Other Outcome Measures:
  1. Exploratory: Correlation of RNA biomarkers [ Time Frame: 2 yrs ]
    Correlation of RNA biomarkers with local control



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 included in brainmetgpa.com, an estimated median survival no less than 6 months per brainmetgpa.com
  5. For unknown primary or known primary not included within brainmetgpa.com, an estimated median survival no less than 6 months per PI discretion Note: If patient's estimated median survival is calculated using a histology that is different than the histology demonstrated in final pathology, the patient may remain eligible for all study endpoints per PI discretion
  6. Surgical candidate per neurosurgeon discretion
  7. Surgical resection able to be performed within 1 - 4 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. This will be assessed by the consenting physician using general questions to determine the patient's ability to understand the medical problem, proposed treatment, alternatives to proposed treatment, and understand the consequences of the medical choices.
  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
  13. If a patient who meets all stated eligibility criteria is enrolled on study and then discovered to be ineligible, the tissue obtained will still be deemed eligible to remain in study for evaluation.

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 - 4 days after radiosurgery
  13. Women who are pregnant or nursing are not eligible as treatment involves unforeseeable risks to the fetus or child

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: Kathy Lauer 317 962 8969 klauer@iuhealth.org

Locations
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United States, Indiana
Indiana University Health Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: kathy Lauer    317-962-8969    klauer@iuhealth.org   
Sub-Investigator: Kevin R. Shiue, MD         
Principal Investigator: Namita Agrawal, MD         
Indiana University Health Methodist Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Kathy Lauer    317-962-3172    klauer@iuhealth.org   
Principal Investigator: Namita Agrawal, MD         
Indiana University Melvin and Bren Simon Comprehensive Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Kathy Lauer    318-962-8969    klauer@iuhealth.org   
Sub-Investigator: Kevin R. Shiue, MD         
Principal Investigator: Namita Agrawal, MD         
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Namita Agrawal, MD Indiana University School of Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Namita Agrawal, Assistant Professor of 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: June 4, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
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