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Phase II Pilot Randomized Controlled Trial to Assess Feasibility of "Supra-marginal" Surgical Resection of Malignant Glioma
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?
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.
Age
18 - 85 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
February 5, 2021
Primary Completion Date
February 1, 2025
Completion Date
February 1, 2025
Last Updated
June 18, 2023
72
ESTIMATED participants
Supramarginal resection
PROCEDURE
Conventional (i.e. GTR) resection
PROCEDURE
Lead Sponsor
Sunnybrook Health Sciences Centre
Collaborators
NCT05839379
NCT07042620
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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