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COMPLETED
NCT04737577
NA

Glioma Supra Marginal Incision Trial

Sponsor: Sunnybrook Health Sciences Centre

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

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.

PROCEDURE

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