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NCT Number: NCT04737577

Glioma Supra Marginal Incision Trial

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?

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Key information

Conditions

High Grade Glioma Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Glioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mackenzie Health Sciences Center, Edmonton, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Radiographic evidence of a GAD-enhancing intra-axial tumor consistent with HGG;
  • Age ≥18 ≤ 85 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);
  • Known metastatic cancer;
  • Uncorrectable coagulopathy;
  • Unable to obtain GAD-enhanced brain MRI.

Treatment and study plan

Supramarginal resection

Procedure

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.

Conventional (i.e. GTR) resection

Procedure

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

Primary outcomes

  1. Enrollment

    Time frame: Collected at time of randomization, through end of enrollment period (2 years)

    The number of patients enrolled and successfully allocated to the intervention versus the control treatment

Secondary outcomes

  1. Feasibility using eligibility

    Time frame: Screening/Enrollment

    Measures feasibility. Among all screened patients, the proportion of patients who meet the eligibility criteria

  2. Feasibility using proportion of consent

    Time frame: Screening/Enrollment

    Measures feasibility. Among all screened patients, the proportion of patients consenting to participate

  3. Feasibility using number of completed visits

    Time frame: Through study completion, on average 2 years

    Measures feasibility. Among all screened patients, the proportion of patients completing all scheduled follow-up assessments

  4. Feasibility using Gross Total Resection

    Time frame: 2 days (+/- 1 day) post surgery

    Measures feasibility. The proportion of radiographically-confirmed gross total resection of contrast-enhancing tumor based on the first MRI after surgery.

  5. Efficacy using overall survival

    Time frame: 6 weeks (+/- 2 weeks), 6 months (+/- 2 weeks) and 12 (+/- 1) months post surgery

    Measures efficacy. The date of death will be obtained from hospital records, outpatient follow up clinic notes, or provincial cancer registries.

  6. Efficacy using progression-free survival

    Time frame: 6 weeks (+/- 2 weeks), 6 months (+/- 2 weeks) and 12 (+/- 1) months post surgery

    Measures efficacy. Assessment of progression-free survival based on the Modified Criteria for Radiographic Response Assessment in Glioblastoma (mRANO) criteria. The date of death will be obtained from hospital records, outpatient follow up clinic notes, or provincial cancer registries. Progression-free survival will be measured based on mRANO criteria during regular 3-month interval clinical and MRI follow up

  7. Safety using neurological function

    Time frame: 2 (+/- 1) days and 6 weeks (+/- 2 weeks), days post surgery

    The NIH Stroke Scale (NIHSS) will be used to assess neurological function. The NIHSS is a validated neurologically-specific outcome tool originally developed for rapid grading of stroke symptoms adopted in surgical clinical trials as well.

  8. Safety using global disability

    Time frame: 6 months (+/- 2 weeks) and 12 (+/- 1) months post surgery

    The modified rankin scale (mRS ) is a measure of global disability that has been widely used to assess outcome after stroke.

    The scale consists of six grades from 0 (no symptoms) to 5 (severe disability); 6 indicates death.

  9. Safety using quality of life

    Time frame: 6 months (+/- 2 weeks) and 12 (+/- 4 weeks) post surgery, 24 (+/- 4 weeks) post surgery

    The overall quality of life will be assessed either in-person or over the phone using the EuroQol-5 (EQ-5D). The EQ-5D is a generic instrument used to measure quality of life, designed for self-completion by respondents either face-to-face or over telephone interview, also available in proxy version through care giver.

  10. Safety using 6 weeks (+/- 2 weeks) all cause-mortality

    Time frame: 6 weeks (+/- 2 weeks) post surgery

    Will collect mortality data.

  11. Radiological

    Time frame: 2 (+/- 1) days, 6 months (+/- 2 weeks) and 12 (+/- 1) months

    Volumetric measurement of contrast enhancement on MRI

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Sunnybrook Research Institute

Registry information

Official study title

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

Acronym: G-SUMIT

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Feb 4, 2021
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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