What side effects are associated with this type of intervention?

Common treatments for brain tumors, including extended resection margins, can have several side effects. Surgical resection, especially when extending beyond the visible tumor, may lead to neurological deficits, such as motor or language impairments, depending on the tumor's location. Intraoperative imaging and fluorescence-guided surgery aim to maximize tumor removal while minimizing damage to healthy tissue, but risks still include infection, bleeding, and swelling. Radiation therapy can cause fatigue, hair loss, and cognitive changes, while chemotherapy may lead to nausea, vomiting, and increased susceptibility to infections. Each treatment's side effects vary based on individual patient factors and the specific techniques used.

What prior FDA approvals exist?

The FDA has approved several treatments for brain tumors, including surgical resection techniques and adjuvant therapies. One notable FDA-approved treatment is the use of 5-aminolevulinic acid (5-ALA) for fluorescence-guided surgery, which helps surgeons achieve a more complete resection of malignant gliomas by highlighting cancerous tissues. This approach aligns with the concept of extended resection margins, as it aims to maximize the removal of tumor cells. Additionally, the FDA has approved various chemotherapeutic agents and targeted therapies, such as temozolomide for glioblastoma, which is often used in conjunction with surgical resection to improve patient outcomes.

What other types of research exist?

Promising alternatives to extended resection margin for brain tumor patients include intraoperative MRI guidance, fluorescence-guided surgery with 5-aminolevulinic acid (5-ALA), and advanced intraoperative imaging technologies. These techniques help achieve more precise tumor removal and may improve survival rates while reducing the risk of neurological deficits.

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Supramarginal Resection for Brain Cancer (G-SUMIT Trial)

N/A

Recruiting

Led By Alireza Mansouri, MD MSc FRCSC

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

Must not have

Multi-focal tumor, gliomatosis cerebri (≥3 lobes of the brain affected), tumors crossing the midline, or leptomeningeal enhancement

Known metastatic cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, on average 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if removing an extra 1 cm of brain tissue around a newly diagnosed high-grade glioma can help patients live longer and prevent cancer from returning. It focuses on patients with tumors in locations suitable for this type of surgery.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My brain tumor affects multiple areas or has spread across the middle of my brain.

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My cancer has spread to other parts of my body.

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I have a blood clotting disorder that cannot be corrected.

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I have had surgery to remove a brain tumor.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Enrollment

Secondary study objectives

Efficacy using overall survival

Efficacy using progression-free survival

Feasibility using Gross Total Resection

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for brain tumors include surgical resection, radiation therapy, and chemotherapy. Surgical resection aims to physically remove as much of the tumor as possible, which can alleviate symptoms and potentially extend survival. Extended resection margins, such as removing an additional 1 cm beyond the visible tumor, may further reduce the risk of recurrence by ensuring that microscopic tumor cells are also removed. Radiation therapy uses high-energy beams to destroy cancer cells and shrink tumors, while chemotherapy employs drugs to kill or inhibit the growth of cancer cells. These treatments are crucial for brain tumor patients as they target the tumor from different angles, potentially improving overall survival and quality of life.

Interrelationships between molecular subtype, anatomical location, and extent of resection in diffuse glioma: a systematic review and meta-analysis.Adult primary high-grade spinal glioma: a nationwide analysis of current trends in treatment and outcomes.Long-term outcome and survival of surgically treated supratentorial low-grade glioma in adult patients.