Clinical trial NCT04737577: Glioma Supra Marginal Incision Trial
Official title: Phase II Pilot Randomized Controlled Trial to Assess Feasibility of "Supra-marginal" Surgical Resection of Malignant Glioma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: High Grade Glioma
Keywords: Supramarginal resection
Standard total resection
Surgery
Brain tumor
HGG
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Sunnybrook Research Institute
First posted: 2021-02-04
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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?

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Radiographic evidence of a GAD-enhancing intra-axial tumor consistent with HGG;
2. Age ≥18 ≤ 85 years;
3. Karnofsky Performance Score ≥ 60;
4. Location of tumor in a safe anatomical location and
5. Patient or substitute decision maker (SDM) able to understand and consent to study participation.

Exclusion Criteria:

1. Multi-focal tumor, gliomatosis cerebri (≥3 lobes of the brain affected), tumors crossing the midline, or leptomeningeal enhancement;
2. Previous craniotomy for tumor excision (stereotactic biopsy is permitted);
3. Known metastatic cancer;
4. Uncorrectable coagulopathy;
5. Unable to obtain GAD-enhanced brain MRI.

Primary outcomes:
measure: Enrollment
timeFrame: Collected at time of randomization, through end of enrollment period (2 years)
Secondary outcomes:
measure: Feasibility using eligibility
timeFrame: Screening/Enrollment
measure: Feasibility using proportion of consent
timeFrame: Screening/Enrollment
measure: Feasibility using number of completed visits
timeFrame: Through study completion, on average 2 years
measure: Feasibility using Gross Total Resection
timeFrame: 2 days (+/- 1 day) post surgery
measure: Efficacy using overall survival
timeFrame: 6 weeks (+/- 2 weeks), 6 months (+/- 2 weeks) and 12 (+/- 1) months post surgery
measure: Efficacy using progression-free survival
timeFrame: 6 weeks (+/- 2 weeks), 6 months (+/- 2 weeks) and 12 (+/- 1) months post surgery
measure: Safety using neurological function
timeFrame: 2 (+/- 1) days and 6 weeks (+/- 2 weeks), days post surgery
measure: Safety using global disability
timeFrame: 6 months (+/- 2 weeks) and 12 (+/- 1) months post surgery
measure: Safety using quality of life
timeFrame: 6 months (+/- 2 weeks) and 12 (+/- 4 weeks) post surgery, 24 (+/- 4 weeks) post surgery
measure: Safety using 6 weeks (+/- 2 weeks) all cause-mortality
timeFrame: 6 weeks (+/- 2 weeks) post surgery
measure: Radiological
timeFrame: 2 (+/- 1) days, 6 months (+/- 2 weeks) and 12 (+/- 1) months
Other outcomes:
Locations:
city: University Park
country: United States
facility: The Pennsylvania State University
state: Pennsylvania
city: Edmonton
country: Canada
facility: Mackenzie Health Sciences Center
state: Alberta
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Farhad Pirouzmand, MD, MSc, FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: Penn State Cancer Institute
name: Alireza Mansouri, MD MSc FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Centre
name: Damon Scales, MD, PhD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mansouri A, Lai C, Scales D, Pirouzmand F. A phase II pilot randomized controlled trial to assess the feasibility of the "supra-marginal" surgical resection of malignant glioma (G-SUMIT: Glioma supra marginal incision trial) study protocol. Pilot Feasibility Stud. 2022 Jul 5;8(1):138. doi: 10.1186/s40814-022-01104-1.