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Supramarginal Resection for Brain Cancer (G-SUMIT Trial)

N/A

Recruiting

Led By Damon Scales, MD, PhD, FRCPC

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient or substitute decision maker (SDM) able to understand and consent to study participation

Radiographic evidence of a GAD-enhancing intra-axial tumor consistent with HGG

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, on average 2 years

Awards & highlights

G-SUMIT Trial Summary

This trial is to see if removing more of the tumor results in better outcomes for patients with HGG.

Who is the study for?

This trial is for adults aged 18-80 with a first-time high-grade glioma brain tumor in a location that's safe to operate on. They must have a Karnofsky Performance Score of at least 60, be able to consent, and have an MRI showing the tumor. It's not for those who've had previous craniotomy (except biopsy), other cancers, blood clotting issues, or certain types of widespread brain tumors.Check my eligibility

What is being tested?

The G-SUMIT trial is testing if cutting out an extra centimeter around the visible tumor on MRI improves overall survival without worsening neurological function or quality of life after surgery. Patients are randomly assigned to either this new 'supramarginal' resection method or the standard one.See study design

What are the potential side effects?

Potential side effects may include typical surgical risks like infection and bleeding, as well as possible neurological changes due to more extensive tissue removal around the tumor.

G-SUMIT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I or someone who makes decisions for me can understand and agree to join the study.

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My brain tumor shows up on MRI scans with a specific contrast.

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I can care for myself but may need occasional help.

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I am between 18 and 80 years old.

G-SUMIT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, on average 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, on average 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, on average 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Enrollment

Secondary outcome measures

Efficacy using overall survival

Efficacy using progression-free survival

Feasibility using Gross Total Resection

+8 more

G-SUMIT Trial Design

2Treatment groups

Experimental Treatment

Group I: Supramarginal resection (intervention arm)Experimental Treatment1 Intervention

Planned 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.

Group II: Conventional (i.e. GTR) resectionExperimental Treatment1 Intervention

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sunnybrook Research InstituteOTHER

31 Previous Clinical Trials

215,747 Total Patients Enrolled

Sunnybrook Health Sciences CentreLead Sponsor

656 Previous Clinical Trials

1,551,236 Total Patients Enrolled

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,345 Previous Clinical Trials

26,453,695 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being considered for this experiment?

"Indeed, according to the clinicaltrials.gov website, this medical study is currently enrolling participants. First posted on February 5th 2021 and most recently updated on May 5th 2022, the trial seeks 72 patients at a single location."

Answered by AI

Is the minimum age requirement for this research project 20 or above?

"To be eligible for this clinical trial, patients must be aged between 18 to 80 years old."

Answered by AI

Who has the opportunity to take part in this research study?

"This trial is searching for 72 individuals suffering from glioma between 18 and 80 years of age. To be eligible, applicants must meet the following qualifications: comprehension and consent to study enrollment provided by either patient or their SDM, radiographic verification of a gadolinium-enhancing intra-axial tumour compatible with HGG, minimum KPS score of 60, safe anatomical location of neoplasm."

Answered by AI

What is the largest size of the total participant pool for this clinical investigation?

"Affirmative. According to clinicaltrials.gov, this medical trial remains open for recruitment and has been amended on May 5th 2022 since its initial listing of February 5th 2021. At the moment, 72 participants are needed from one particular site."

Answered by AI

Recent research and studies

Pilot and Feasibility StudiesJournal

A Phase II Pilot Randomized Controlled Trial to Assess the Feasibility of the “supra-marginal

Mansouri, Alireza, Carolyn Lai, Damon Scales, and Farhad Pirouzmand. 2022. “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 and Feasibility Studies. Springer Science and Business Media LLC. doi:10.1186/s40814-022-01104-1.

clinicaltrials.govStudy

Glioma Supra Marginal Incision Trial

2021. "Glioma Supra Marginal Incision Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04737577.