Glioma Supra Marginal Incision Trial
Status unconfirmed · Not applicable
Conditions studied: High Grade Glioma
In brief
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?
Key facts
- Study ID
- NCT04737577
- Run by
- Sunnybrook Health Sciences Centre
- People needed
- 72
- Starts
- 2021-02-05
- Expected to finish
- 2025-02-01
- Last updated by the study team
- 2023-06-18
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Radiographic evidence of a GAD-enhancing intra-axial tumor consistent with HGG;
- Age ≥18 ≤ 85 years;
- Karnofsky Performance Score ≥ 60;
- Location of tumor in a safe anatomical location and
- Patient or substitute decision maker (SDM) able to understand and consent to study participation.
You may not qualify if…
- Multi-focal tumor, gliomatosis cerebri (≥3 lobes of the brain affected), tumors crossing the midline, or leptomeningeal enhancement;
- Previous craniotomy for tumor excision (stereotactic biopsy is permitted);
- Known metastatic cancer;
- Uncorrectable coagulopathy;
- Unable to obtain GAD-enhanced brain MRI.
Where it is running
- The Pennsylvania State University — University Park, Pennsylvania, United States (enrolling)
- Mackenzie Health Sciences Center — Edmonton, Alberta, Canada (enrolling)
- Kingston Health Sciences Centre — Kingston, Ontario, Canada (enrolling)
- St Michael's Hospital — Toronto, Ontario, Canada (enrolling)
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (enrolling)
- University of Saskatchewan — Saskatoon, Saskatchewan, Canada (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.