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Completed NCT04737577

Glioma Supra Marginal Incision Trial

Conditions: High Grade Glioma

Sex: All
Ages: 18 Years – 85 Years
Healthy volunteers: No
Phase: NA
Enrollment: 44
Sponsor: Sunnybrook Health Sciences Centre

Location: The Pennsylvania State University University Park Pennsylvania

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?

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04737577). StuddyBuddy aggregates publicly available trial information.