Glioma Supra Marginal Incision Trial (G-SUMIT)
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- STATUS
- Recruiting
-
- End date
- Feb 28, 2025
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- participants needed
- 72
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- 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?
Description
This pilot, multi-centre, pragmatic randomized controlled trial is planned to simulate all aspects of a larger definitive trial comparing conventional versus supramarginal tumor resection at the time of the first surgical resection of HGG in appropriately selected patients. This pilot will help determine the ability to meet pre-specified criteria in identification, recruitment, and patient allocation, allow for refinement of eligibility criteria for optimal recruitment, confirm safety of procedure and ability to retain participants for the duration of the trial. Preliminary efficacy data will inform sample size calculations and estimation of resources required for the envisioned larger definitive trial.
Details
| Condition | High Grade Glioma |
|---|---|
| Treatment | Supramarginal resection, Conventional (i.e. GTR) resection |
| Clinical Study Identifier | NCT04737577 |
| Sponsor | Sunnybrook Health Sciences Centre |
| Last Modified on | 29 May 2022 |
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