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Preoperative SRS/SRT vs Postoperative SRS/SRT for Brain Metastases

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ClinicalTrials.gov Identifier: NCT04422639
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : July 9, 2021
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Brief Summary:

This pilot study is a randomized, open-label, 2-arm active-controlled phase II clinical trial conducted at a single study site (UAMS). Subjects will be randomized to one of the 2 treatment arms and stratified by size of index lesion and number of brain metastases.

The investigators will prospectively compare preoperative (neoadjuvant) SRS/SRT to postoperative (adjuvant) SRS/SRT in patients undergoing surgical resection for brain metastases.

The investigators hypothesize that neoadjuvant SRS/SRT prior to surgical resection of brain metastases will result in improved freedom from Central Nervous System (CNS) events when compared to adjuvant SRS/SRT after surgical resection.


Condition or disease Intervention/treatment Phase
Brain Metastases Radiation: SRS/SRT Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Pilot Trial of Preoperative SRS/SRT Versus Postoperative SRS/SRT for Brain Metastases
Actual Study Start Date : August 24, 2020
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2024

Arm Intervention/treatment
Experimental: Arm I (pre-operative SRS/SRT)
Patients undergo SRS or SRT within 15 days of randomization followed by surgery within 15 days of radiation completion. Patients may undergo additional SRS or SRT if disease returns after treatment.
Radiation: SRS/SRT
Comparing pre-operative SRS/SRT to post-operative SRS/SRT

Active Comparator: Arm II (post-operative SRS/SRT)
Patients undergo surgery within 15 days of randomization followed by standard-of-care SRS or SRT within 30 days of surgery. Patients may undergo additional SRS or SRT if disease returns after treatment.
Radiation: SRS/SRT
Comparing pre-operative SRS/SRT to post-operative SRS/SRT




Primary Outcome Measures :
  1. Time to a Central Nervous System (CNS) Composite Event (CE) [ Time Frame: From date of randomization to the date of a documented LR, SRN, or LMD, whichever comes first, assessed up to 18 months. ]
    A CNS CE will consist of one of the following three events: Local Recurrence (LR) of the treated lesions, symptomatic radiation necrosis (SRN) to the treated lesions, or development of leptomeningeal disease (LMD).



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:

  • Patients with prior histopathological diagnosis of cancer other than small cell lung cancer, lymphoma, and germ cell histologies.
  • MR imaging of the brain with findings strongly suggestive of metastatic tumor(s) as assessed by the radiologist.
  • Seen by a neurosurgeon or radiation oncologist and judged to be appropriate for participation in this study, including the ability to tolerate both surgery and SRS/SRT, e.g., the ability to lie flat in a stereotactic soft head frame.
  • ECOG ≤ 2
  • 1-2 index lesion(s) appropriate for resection, not previously treated with SRS/SRT.

Index lesion(s) should be > 2 cm and < 5 cm in largest dimension, and require resection. Alternatively, patients with a diagnosis of melanoma and a lesion < 1.5cm in largest dimension may also be included. o All other brain lesions must be appropriate for SRS/SRT alone and treated according to physician preference. Prior neurosurgery and/or prior SRS/SRT at a non-overlapping location are permitted at the discretion of the treating physician.

- MRI confirmed 1-10 lesions, 1-2 of which are the index lesions undergoing surgery.

Each non-index lesion (up to 10) must measure ≤ 3.0 cm in maximal extent on contrasted MRI scan, and not otherwise require resection.

  • Clinical indication and plan for stereotactic radiosurgery to all known brain lesions requiring treatment (≤ 10 metastases).
  • Surgical resection able to be performed within 15 days of radiotherapy completion.
  • Written informed consent obtained from subject, or a legally designated power of attorney and ability for subject to comply with the requirements of the study.
  • Negative pregnancy test in women of childbearing potential (WOCBP) within 30 days of radiation. WOCBP is a female patient less than 50 years of age or who has menstruated within the last 12 months.
  • Platelet count > 80 k/cumm, Hgb > 7.5 gm/dL, INR < 1.3, ANC > 1.5 k/cumm

Exclusion Criteria:

  • Not a surgical candidate per neurosurgeon's discretion.
  • Contraindication to general anesthesia.
  • Not a radiosurgical candidate per radiation oncologist's discretion.
  • Metastatic germ cell tumor, small cell carcinoma, leukemia, multiple myeloma or lymphoma or any primary brain tumor
  • ECOG > 2
  • < 3 months expected survival
  • Radiologic documentation of hydrocephalus in addition to symptoms of hydrocephalus
  • Radiographic or cytologic evidence of leptomeningeal disease.
  • Imaging Findings:

    • Midline shift > 6mm
    • >10 lesions, one of which is the index lesion
    • Largest lesion > 5cm
  • Pregnancy
  • Known allergy to gadolinium, pacemaker, or other contraindication such as metal implant that is not safe for MRI. Patients with MRI-compatible implants are eligible.
  • Patients who have local recurrence of previously treated brain metastasis.
  • Patients who have received prior WBRT.
  • Inherited radiation hypersensitivity syndromes

    o Ataxia Telangiectasia, Nijmegen Breakage Syndrome, Fanconi Anemia, DNA Ligase IV, Mre 11 deficiency, SCID, Bloom's syndrome

  • Collagen vascular diseases

    o Active systemic lupus erythematous (SLE), scleroderma, mixed connective tissue disorder, polymyositis or dermatomyositis, CREST Syndrome

  • Cytotoxic Chemotherapy within 7 days prior to SRS/SRT.

    o Molecularly targeted therapies, including immune-modulatory drugs, can be given within 7 days of SRS/SRT at the discretion of the treating physician.

  • Patients who received anti-VEGF therapy within 6 weeks prior to enrollment, as there is increased risk of fatal brain hemorrhage with surgical resection.
  • Treatment plan respecting normal tissue tolerances using dose fractionation specified within the protocol cannot be achieved.

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): NCT04422639


Contacts
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Contact: Beth Scanlan 5016868274 bscanlan@uams.edu

Locations
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United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72223
Contact: Beth Scanlan, MAP    501-686-8274    bscanlan@uams.edu   
Principal Investigator: Analiz Rodriguez, MD, PhD         
Sponsors and Collaborators
University of Arkansas
Investigators
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Principal Investigator: Analiz Rodriguez, MD, PhD UAMS
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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT04422639    
Other Study ID Numbers: 260505
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: July 9, 2021
Last Verified: July 2021

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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
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Neoplastic Processes
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases