Clinical Trials /

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

NCT03398694

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Pre-operative Stereotactic Radiosurgery Followed by Resection for Patients With Brain Metastases
  • Official Title: A Phase II Study Analyzing Pre-operative Stereotactic Radiosurgery Followed by Resection for Patients With 1 - 4 Brain Metastases

Clinical Trial IDs

  • ORG STUDY ID: IUSCC-0627
  • SECONDARY ID: 1707314702
  • NCT ID: NCT03398694

Conditions

  • Brain Metastases

Purpose

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.

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
    

Trial Arms

NameTypeDescriptionInterventions
Arm 1ExperimentalThis 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.

    Eligibility 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
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Rate of local control of any new, recurrent, or progressing tumors within the planning target volume
    Time Frame:6 months
    Safety Issue:
    Description:Measured by post-treatment MRI

    Secondary Outcome Measures

    Measure:Rate of overall survival
    Time Frame:6 months, 1 year, and 2 years
    Safety Issue:
    Description:Time from start of treatment to death of any cause
    Measure:Rate of in-brain progression free survival
    Time Frame:6 months, 1 year, and 2 years
    Safety Issue:
    Description:Time from start of treatment to any in-brain
    Measure:Proportion of patients with distant in-brain failure (any new parenchymal lesion outside of the planning target volume)
    Time Frame:2 years
    Safety Issue:
    Description:Measured by post-treatment MRI
    Measure:Proportion of patients with radiation necrosis (radiographic or biopsy-positive diagnosis of radiation necrosis)
    Time Frame:2 years
    Safety Issue:
    Description:Measured by post-treatment MRI
    Measure:Proportion of patients with leptomeningeal spread (radiographic or CSF diagnosis of leptomeningeal disease)
    Time Frame:2 years
    Safety Issue:
    Description:Measured by post-treatment MRI

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Indiana University

    Last Updated