Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
72 participants
INTERVENTIONAL
2021-02-05
2025-02-28
Brief Summary
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Does extending the margin of resection 1 cm beyond visible enhanced volume on MRI result in (a) an increase in overall survival? (b) result in a similar rate of "clinically-significant" neurological worsening during 30 days post surgery and quality of life at 6 and 12 months?
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Supramarginal resection (intervention arm)
Planned resection beyond the Gadolinium (GAD)-enhancing region extending to either at least 1 cm into non-enhancing tissue, or the nearest non-enhancing sulcal boundary/ventricle wall if these structures are closer than 1 cm.
Supramarginal resection
Tissue removal beyond the GAD-enhancing region extending to either at least 1 cm into non-enhancing tissue, or the nearest non-enhancing sulcal boundary/ventricle wall if these structures are closer than 1 cm.
Conventional (i.e. GTR) resection
Planned resection of ≥95% of the GAD-enhancing regions of tumor without expanding the resection beyond this margin.
Conventional (i.e. GTR) resection
Planned resection of ≥95% of the GAD-enhancing regions of tumor without expanding the resection beyond this margin.
Interventions
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Supramarginal resection
Tissue removal beyond the GAD-enhancing region extending to either at least 1 cm into non-enhancing tissue, or the nearest non-enhancing sulcal boundary/ventricle wall if these structures are closer than 1 cm.
Conventional (i.e. GTR) resection
Planned resection of ≥95% of the GAD-enhancing regions of tumor without expanding the resection beyond this margin.
Eligibility Criteria
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Inclusion Criteria
2. Age ≥18 ≤ 85 years;
3. Karnofsky Performance Score ≥ 60;
4. Location of tumor in a safe anatomical location and
5. Patient or substitute decision maker (SDM) able to understand and consent to study participation.
Exclusion Criteria
2. Previous craniotomy for tumor excision (stereotactic biopsy is permitted);
3. Known metastatic cancer;
4. Uncorrectable coagulopathy;
5. Unable to obtain GAD-enhanced brain MRI.
18 Years
85 Years
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Sunnybrook Research Institute
OTHER
Sunnybrook Health Sciences Centre
OTHER
Responsible Party
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Principal Investigators
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Farhad Pirouzmand, MD, MSc, FRCSC
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Health Sciences Centre
Alireza Mansouri, MD MSc FRCSC
Role: PRINCIPAL_INVESTIGATOR
Penn State Cancer Institute
Damon Scales, MD, PhD, FRCPC
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Health Sciences Centre
Locations
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The Pennsylvania State University
University Park, Pennsylvania, United States
Mackenzie Health Sciences Center
Edmonton, Alberta, Canada
Kingston Health Sciences Centre
Kingston, Ontario, Canada
St Michael's Hospital
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
University of Saskatchewan
Saskatoon, Saskatchewan, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Mansouri A, Lai C, Scales D, Pirouzmand F. A phase II pilot randomized controlled trial to assess the feasibility of the "supra-marginal" surgical resection of malignant glioma (G-SUMIT: Glioma supra marginal incision trial) study protocol. Pilot Feasibility Stud. 2022 Jul 5;8(1):138. doi: 10.1186/s40814-022-01104-1.
Other Identifiers
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CTO 3297
Identifier Type: -
Identifier Source: org_study_id
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