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High Grade GliomaG-SUMITNCT04737577

Glioma Supra Marginal Incision Trial

A study testing Supramarginal resection and Conventional (i.e. GTR) resection in people with High Grade Glioma, run by Sunnybrook Health Sciences Centre at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
High Grade Glioma
What is being tested?
Supramarginal resection and Conventional (i.e. GTR) resection
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
6 sitesin 2 countries
Study dates
5 Feb 2021to 30 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

Canada5 sites

  • Mackenzie Health Sciences Center

    Edmonton, Alberta, T6G 2B7

  • Kingston Health Sciences Centre

    Kingston, Ontario, K7L 2V7

  • University of Saskatchewan

    Saskatoon, Saskatchewan

  • St Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario

Other trials in Canada

United States1 site

  • The Pennsylvania State University

    University Park, Pennsylvania, 16802

Other trials in United States

About this study

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

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?

Read the detailed 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.

Being tested
Supramarginal resection, Conventional (i.e. GTR) resection
Keywords
Supramarginal resection, Standard total resection, Surgery, Brain tumor, HGG
Medical subject headings
Glioma, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Supramarginal resectionProcedure or surgery

    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) resectionProcedure or surgery

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

Study groups in NCT04737577
Study groupRoleWhat they receive
Supramarginal resection (intervention arm)ExperimentalPlanned resection beyond the Gadolinium (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.
Receives: Procedure: Supramarginal resection
Conventional (i.e. GTR) resectionOtherPlanned resection of ≥95% of the GAD-enhancing regions of tumor without expanding the resection beyond this margin.
Receives: Procedure: Conventional (i.e. GTR) resection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Enrollment

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

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

Secondary outcomes (11)

  1. Feasibility using eligibility

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

    Measured: Screening/Enrollment

  2. Feasibility using proportion of consent

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

    Measured: Screening/Enrollment

  3. Feasibility using number of completed visits

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

    Measured: Through study completion, on average 2 years

  4. Feasibility using Gross Total Resection

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

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

  5. Efficacy using overall survival

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

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

  6. Efficacy using progression-free survival

    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

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

  7. Safety using neurological function

    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.

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

  8. Safety using global disability

    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.

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

  9. Safety using quality of life

    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.

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

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

    Will collect mortality data.

    Measured: 6 weeks (+/- 2 weeks) post surgery

  11. Radiological

    Volumetric measurement of contrast enhancement on MRI

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2021
  2. Study start5 Feb 2021
  3. Primary completion30 Dec 2025
  4. Study completion30 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04737577
Sponsor's protocol ID
CTO 3297
Acronym
G-SUMIT
Status last verified
Jun 2023
First submitted
19 Jan 2021
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The deidentified individual participant data underlying the published results will be made available to qualified investigators whose proposed use has been approved by the G-SUMIT steering committee and Ethics Board. For requests involving the pooled dataset, approval from both trial steering committees would be required. Data would be available beginning 12 months after publication and for 5 years after publication. Access would be subject to a methodologically sound proposal, applicable institutional and privacy requirements, and completion of an appropriate data-use agreement. Requests would be directed to the corresponding author.

Publications

  • Mansouri A, Lai C, Scales D, Pirouzmand F. A phase II pilot randomized controlled trial to assess the feasibility of the "supra-marginal" surgical resection of malignant glioma (G-SUMIT: Glioma supra marginal incision trial) study protocol. Pilot Feasibility Stud. 2022 Jul 5;8(1):138. doi: 10.1186/s40814-022-01104-1.

    PubMed 35791008

Questions about this trial

What is this clinical trial studying?

A study testing Supramarginal resection and Conventional (i.e. GTR) resection in people with High Grade Glioma, run by Sunnybrook Health Sciences Centre at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Enrollment (time frame: Collected at time of randomization, through end of enrollment period (2 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04737577, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.

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