Glioma Supra Marginal Incision Trial

Description

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

High Grade Glioma

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Study Overview

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Study Details

Study overview

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?

Phase II Pilot Randomized Controlled Trial to Assess Feasibility of "Supra-marginal" Surgical Resection of Malignant Glioma

Glioma Supra Marginal Incision Trial

Condition
High Grade Glioma
Intervention / Treatment

-

Contacts and Locations

University Park

The Pennsylvania State University, University Park, Pennsylvania, United States, 16802

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sunnybrook Health Sciences Centre,

Farhad Pirouzmand, MD, MSc, FRCSC, PRINCIPAL_INVESTIGATOR, Sunnybrook Health Sciences Centre

Alireza Mansouri, MD MSc FRCSC, PRINCIPAL_INVESTIGATOR, Penn State Cancer Institute

Damon Scales, MD, PhD, FRCPC, PRINCIPAL_INVESTIGATOR, Sunnybrook Health Sciences Centre

Study Record Dates

2025-02