Glioma Supra Marginal Incision Trial

Last updated: June 15, 2023
Sponsor: Sunnybrook Health Sciences Centre
Overall Status: Active - Recruiting

Phase

N/A

Condition

Brain Tumor

Astrocytoma

Brain Cancer

Treatment

Supramarginal resection

Conventional (i.e. GTR) resection

Clinical Study ID

NCT04737577
CTO 3297
  • Ages 18-85
  • All Genders

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?

Eligibility Criteria

Inclusion

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 studyparticipation.

Exclusion

Exclusion Criteria:

  1. Multi-focal tumor, gliomatosis cerebri (≥3 lobes of the brain affected), tumorscrossing 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.

Study Design

Total Participants: 72
Treatment Group(s): 2
Primary Treatment: Supramarginal resection
Phase:
Study Start date:
February 05, 2021
Estimated Completion Date:
February 28, 2025

Study Description

This pilot, multi-centre, pragmatic randomized controlled trial is planned to simulate all aspects of a larger definitive trial comparing conventional versus supramarginal tumor resection at the time of the first surgical resection of HGG in appropriately selected patients. This pilot will help determine the ability to meet pre-specified criteria in identification, recruitment, and patient allocation, allow for refinement of eligibility criteria for optimal recruitment, confirm safety of procedure and ability to retain participants for the duration of the trial. Preliminary efficacy data will inform sample size calculations and estimation of resources required for the envisioned larger definitive trial.

Connect with a study center

  • Mackenzie Health Sciences Center

    Edmonton, Alberta T6G 2B7
    Canada

    Active - Recruiting

  • Kingston Health Sciences Centre

    Kingston, Ontario K7L 2V7
    Canada

    Active - Recruiting

  • St Michael's Hospital

    Toronto, Ontario M5B 1W8
    Canada

    Active - Recruiting

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario
    Canada

    Active - Recruiting

  • University of Saskatchewan

    Saskatoon, Saskatchewan
    Canada

    Active - Recruiting

  • The Pennsylvania State University

    University Park, Pennsylvania 16802
    United States

    Active - Recruiting

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