Evaluating a new surgical approach for high grade glioma
Phase II Pilot Randomized Controlled Trial to Assess Feasibility of "Supra-marginal" Surgical Resection of Malignant Glioma
This study is testing a new surgical method for people with high grade glioma to see if removing more tissue around the tumor can help them live longer without causing more brain problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Locations | 6 sites (University Park, Pennsylvania and 5 other locations) |
| Trial ID | NCT04737577 on ClinicalTrials.gov |
What this trial studies
This pilot trial aims to assess the feasibility of a larger study comparing conventional tumor resection with a supramarginal resection technique for patients with high grade glioma. It will involve a randomized controlled design to determine if extending the surgical margin by 1 cm beyond the visible tumor on MRI can improve overall survival without significantly worsening neurological function. The trial will also refine eligibility criteria and confirm the safety of the procedure while collecting preliminary efficacy data to inform future research. The study will take place across multiple centers to ensure diverse patient recruitment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with a first-time diagnosis of high grade glioma located in a surgically favorable area.
Not a fit: Patients with multifocal tumors, previous surgeries for tumor excision, or known metastatic cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates for patients with high grade glioma.
How similar studies have performed: While similar surgical approaches have been explored, this specific method of supramarginal resection is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
University Park, Pennsylvania and 5 other locations
- The Pennsylvania State University — University Park, Pennsylvania, United States (Recruiting)
- Mackenzie Health Sciences Center — Edmonton, Alberta, Canada (Recruiting)
- Kingston Health Sciences Centre — Kingston, Ontario, Canada (Recruiting)
- St Michael's Hospital — Toronto, Ontario, Canada (Recruiting)
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
- University of Saskatchewan — Saskatoon, Saskatchewan, Canada (Recruiting)
Study contacts
- Principal investigator: Farhad Pirouzmand, MD, MSc, FRCSC — Sunnybrook Health Sciences Centre
- Study coordinator: Farhad Pirouzmand, MD, MSc, FRCSC
- Email: farhad.pirouzmand@sunnybrook.ca
- Phone: 416-480-6100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.