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Glioma Supra Marginal Incision Trial
Sponsor: Sunnybrook Health Sciences Centre
Summary
G-SUMIT is a pilot, phase II,randomized controlled trial to evaluate the feasibility of performing a large-scale trial in patients undergoing surgery for first-time diagnosis of high grade glioma (HGG) in a surgically favorable anatomical location to answer the following: 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?
Official title: Phase II Pilot Randomized Controlled Trial to Assess Feasibility of "Supra-marginal" Surgical Resection of Malignant Glioma
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
44
Start Date
2021-02-05
Completion Date
2025-12-30
Last Updated
2026-08-20
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (6)
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