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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
44
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.
Planned resection of ≥95% of the GAD-enhancing regions of tumor without expanding the resection beyond this margin.
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
Enrollment
The number of patients enrolled and successfully allocated to the intervention versus the control treatment
Time frame: Collected at time of randomization, through end of enrollment period (2 years)
Feasibility using eligibility
Measures feasibility. Among all screened patients, the proportion of patients who meet the eligibility criteria
Time frame: Screening/Enrollment
Feasibility using proportion of consent
Measures feasibility. Among all screened patients, the proportion of patients consenting to participate
Time frame: Screening/Enrollment
Feasibility using number of completed visits
Measures feasibility. Among all screened patients, the proportion of patients completing all scheduled follow-up assessments
Time frame: Through study completion, on average 2 years
Feasibility using Gross Total Resection
Measures feasibility. The proportion of radiographically-confirmed gross total resection of contrast-enhancing tumor based on the first MRI after surgery.
Time frame: 2 days (+/- 1 day) post surgery
Efficacy using overall survival
Measures efficacy. The date of death will be obtained from hospital records, outpatient follow up clinic notes, or provincial cancer registries.
Time frame: 6 weeks (+/- 2 weeks), 6 months (+/- 2 weeks) and 12 (+/- 1) months post surgery
Efficacy using progression-free survival
Measures efficacy. Assessment of progression-free survival based on the Modified Criteria for Radiographic Response Assessment in Glioblastoma (mRANO) criteria. The date of death will be obtained from hospital records, outpatient follow up clinic notes, or provincial cancer registries. Progression-free survival will be measured based on mRANO criteria during regular 3-month interval clinical and MRI follow up
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Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
University of Saskatchewan
Saskatoon, Saskatchewan, Canada
Time frame: 6 weeks (+/- 2 weeks), 6 months (+/- 2 weeks) and 12 (+/- 1) months post surgery
Safety using neurological function
The NIH Stroke Scale (NIHSS) will be used to assess neurological function. The NIHSS is a validated neurologically-specific outcome tool originally developed for rapid grading of stroke symptoms adopted in surgical clinical trials as well.
Time frame: 2 (+/- 1) days and 6 weeks (+/- 2 weeks), days post surgery
Safety using global disability
The modified rankin scale (mRS ) is a measure of global disability that has been widely used to assess outcome after stroke. The scale consists of six grades from 0 (no symptoms) to 5 (severe disability); 6 indicates death.
Time frame: 6 months (+/- 2 weeks) and 12 (+/- 1) months post surgery
Safety using quality of life
The overall quality of life will be assessed either in-person or over the phone using the EuroQol-5 (EQ-5D). The EQ-5D is a generic instrument used to measure quality of life, designed for self-completion by respondents either face-to-face or over telephone interview, also available in proxy version through care giver.
Time frame: 6 months (+/- 2 weeks) and 12 (+/- 4 weeks) post surgery, 24 (+/- 4 weeks) post surgery
Safety using 6 weeks (+/- 2 weeks) all cause-mortality
Will collect mortality data.
Time frame: 6 weeks (+/- 2 weeks) post surgery
Radiological
Volumetric measurement of contrast enhancement on MRI
Time frame: 2 (+/- 1) days, 6 months (+/- 2 weeks) and 12 (+/- 1) months