Glioma Supra Marginal Incision Trial (G-SUMIT)

  • STATUS
    Recruiting
  • End date
    Feb 28, 2025
  • participants needed
    72
  • sponsor
    Sunnybrook Health Sciences Centre
Updated on 29 May 2022

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?

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.

Details
Condition High Grade Glioma
Treatment Supramarginal resection, Conventional (i.e. GTR) resection
Clinical Study IdentifierNCT04737577
SponsorSunnybrook Health Sciences Centre
Last Modified on29 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Radiographic evidence of a GAD-enhancing intra-axial tumor consistent with HGG
Age ≥18 ≤ 80 years
Karnofsky Performance Score ≥ 60
Location of tumor in a safe anatomical location and
Patient or substitute decision maker (SDM) able to understand and consent to study participation

Exclusion Criteria

Multi-focal tumor, gliomatosis cerebri (≥3 lobes of the brain affected), tumors crossing the midline, or leptomeningeal enhancement
Previous craniotomy for tumor excision (stereotactic biopsy is permitted)
Intraoperative histopathological diagnosis not consistent with HGG
Known metastatic cancer
Uncorrectable coagulopathy
Unable to obtain GAD-enhanced brain MRI
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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