Clinical trial · Interventional
Glioma Supra Marginal Incision Trial
Phase II Pilot Randomized Controlled Trial to Assess Feasibility of "Supra-marginal" Surgical Resection of Malignant Glioma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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?
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High Grade Glioma | High-Grade Glioma, NOS | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional (i.e. GTR) resection | Procedure | — | UNRESOLVED |
| Supramarginal resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Supramarginal resection (intervention arm)
- description
- Planned resection beyond the Gadolinium (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.
- interventionNames
- Procedure: Supramarginal resection
- type
- OTHER
- label
- Conventional (i.e. GTR) resection
- description
- Planned resection of ≥95% of the GAD-enhancing regions of tumor without expanding the resection beyond this margin.
- interventionNames
- Procedure: Conventional (i.e. GTR) resection
Primary outcomes (1)
- measure
- Enrollment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDMansouri 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. PMID 35791008