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Glioma Supra Marginal Incision Trial

NCT04737577 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2023-06-18

No results posted yet for this study

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?

Conditions

Interventions

PROCEDURE

Supramarginal resection

Tissue removal beyond the 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.

PROCEDURE

Conventional (i.e. GTR) resection

Planned resection of ≥95% of the GAD-enhancing regions of tumor without expanding the resection beyond this margin.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Sunnybrook Research Institute

    collaborator OTHER

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Farhad Pirouzmand, MD, MSc, FRCSC · Sunnybrook Health Sciences Centre

  • Alireza Mansouri, MD MSc FRCSC · Penn State Cancer Institute

  • Damon Scales, MD, PhD, FRCPC · Sunnybrook Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-05
Primary Completion
2025-02-28
Completion
2025-02-28

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04737577 on ClinicalTrials.gov