Glioma Supra Marginal Incision Trial

Official Title

Phase II Pilot Randomized Controlled Trial to Assess Feasibility of "Supra-marginal" Surgical Resection of Malignant Glioma

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 favourable 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?

Trial Description

Primary Outcome:

• Enrollment

Secondary Outcome:

• Feasibility using eligibility
• Feasibility using proportion of consent
• Feasibility using number of completed visits
• Feasibility using Gross Total Resection
• Efficacy using overall survival
• Efficacy using progression-free survival
• Safety using neurological function
• Safety using global disability
• Safety using quality of life
• Safety using 30-day all cause-mortality
• Radiological

This pilot, multi-centre, pragmatic randomized controlled trial is planned to simulate all aspects of a larger definitive trial comparing conventional versus supramarginal tumour 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.

View this trial on ClinicalTrials.gov