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A Study of Neoadjuvant Stereotactic Radiosurgery for Large Brain Metastases (NASRS)

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: NCT03368625
Recruitment Status : Recruiting
First Posted : December 11, 2017
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
This study will be a non-randomized phase II trial for patients with one to six brain metastases, at least one of which is appropriate for surgical resection. Upon registration, patients will be assigned to receive neo-adjuvant stereotactic radiosurgery (NASRS).

Condition or disease Intervention/treatment Phase
Brain Metastases Radiation: Stereotactic Radiosurgery Not Applicable

Detailed Description:

Recently, a novel treatment strategy for large brain metastases was described whereby lesions appropriate for resection were treated with a single fraction of SRS pre-operatively. In a retrospective analysis, of 51 lesions with a median tumor size of 3 cm, 1-year LC was 86%. This neoadjuvant approach resulted in lower rates of leptomeningeal failure (3 vs. 17%) and symptomatic radiation toxicity (1.5 vs. 14.6 %) compared to a comparative cohort of lesions treated with post-operative cavity boost SRS (POCBS).

Based on promising results, we believe that a prospective trial to establish the value of neoadjuvant SRS (NaSRS) for the treatment of BM appropriate for resection is warranted.

This study will be a non-randomized phase II trial for patients with one to six brain metastases, at least one of which is appropriate for surgical resection. Upon registration, patients will be assigned to receive neo-adjuvant stereotactic radiosurgery (NASRS).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Patients with resectable brain mets will receive neoadjuvant stereotactic radiosurgery prior to surgical resection.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Neoadjuvant Stereotactic Radiosurgery for Large Brain Metastases
Actual Study Start Date : March 19, 2018
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2022

Arm Intervention/treatment
Arm 1
Neoadjuvant SRS
Radiation: Stereotactic Radiosurgery
Stereotactic Radiosurgery before surgical resection of brain mets.




Primary Outcome Measures :
  1. Radiation toxicity [ Time Frame: 1 year ]
    The rate at 1 year of symptomatic (≥grade 2) radiation toxicity


Secondary Outcome Measures :
  1. local control [ Time Frame: 1 year ]
    1-year local control (PR+CR) of the index lesion resulting from NaSRS

  2. leptomeningeal disease [ Time Frame: 1 year ]
    1-year rates of leptomeningeal disease

  3. Survival [ Time Frame: 5 years ]
    Median survival

  4. progression-free survival [ Time Frame: 2 years ]
  5. overall survival [ 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:

  • Lymphoma, small cell carcinoma, and seminoma are excluded
  • A lesion appropriate for resection, not previously treated with SRS. Lesions should be > 2 cm and < 4 cm in largest dimension, and require resection ( e.g. due to mass effect or to obtain a tissue diagnosis). Index lesions will be treated with SRS and surgery, as outlined in the treatment section of the protocol.
  • Seen by a neurosurgeon or radiation oncologist and judged to be appropriate for participation in this study, including the ability to tolerate NaSRS, e.g., the ability to lie flat in a stereotactic head frame.
  • Any unresected lesions or lesions for which there is no planned immediate resection (non index lesions) must measure < 3.0 cm in maximal extent on the contrasted MRI or CT brain scan obtained ≤ 35 days prior to pre-registration. Unresected lesions will be treated with SRS as outlined in the treatment section of the protocol. .
  • ECOG ≤ 2
  • MRI confirmed 1-6 lesions, one of which is the index lesion. Each non-index lesion (up to 5) must measure ≤ 3.0 cm in maximal extent on contrasted MRI scan, and not otherwise require resection.

Note: The pre-registration MRI may be obtained ≤ 35 days prior to enrolment.

Exclusion Criteria:

  • Treatment plan respecting normal tissue tolerances using dose fractionation specified within the protocol cannot be achieved.
  • pregnancy
  • Prior cranial radiotherapy targeting the index lesion, or any prior WBRT.
  • Inability to complete a MRI with contrast of the head, or a known allergy to gadolinium.
  • Cytotoxic Chemotherapy within 7 days prior to SRS (molecularly targeted therapies , including immune-modulatory drugs, can be given within seven days of SRS at the discretion of the treating physician)
  • Metastatic germ cell tumor, small cell carcinoma, or lymphoma or any primary brain tumor
  • Imaging Findings:

    • Widespread definitive leptomeningeal metastasis.
    • A brain metastasis that is located ≤ 2 mm of the optic chiasm
    • Evidence of midline shift
    • Fourth ventricular narrowing, concerning for hydrocephalus

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): NCT03368625


Contacts
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Contact: David Shultz, M.D. 416-946-4501 ext 6899 david.shultz@rmp.uhn.ca

Locations
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Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, L4W4C2
Contact: David Shultz, MD         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: David Shultz, MD University Health Network, Toronto

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03368625    
Other Study ID Numbers: 17-5689
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Health Network, Toronto:
Stereotactic Radiosurgery
Radiation
Surgery
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