Supramaximal vs Maximal Resection for Brain Cancer
(SUPRAMAX Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores new surgical techniques for individuals with high-grade gliomas (HGG), a type of brain tumor. Researchers compare two methods: removing only the visible tumor versus removing both the visible tumor and the surrounding non-visible tissue. The goal is to determine which approach improves survival, brain function, and quality of life. Individuals diagnosed with HGG who are considering surgical options might be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that both supramaximal resection (SMR) and maximal safe resection are generally well-tolerated surgeries for treating high-grade glioma, a type of brain tumor.
For SMR, studies have found that removing more of the tumor can help patients live longer. However, this procedure can sometimes lead to side effects. Specifically, one study found that patients who underwent SMR lived an average of 21.6 months, though it did not specify the side effects. While SMR might extend life, it is important to consider possible risks, such as changes in brain function.
Maximal safe resection is also considered safe. In one study, 77.7% of patients had stable or improved function after surgery. Another study found that only 4.9% of patients experienced new brain-related issues. This suggests that maximal safe resection is often well-tolerated and can help maintain quality of life.
Both surgeries aim to remove as much of the tumor as possible while preserving brain functions. It is important to discuss the risks and benefits with doctors to understand the best approach for each specific situation.12345Why are researchers excited about this trial?
Researchers are excited about the SUPRAMAX study because it explores a new surgical technique called supramaximal resection for treating high-grade gliomas, which are aggressive brain tumors. Unlike the standard maximal safe resection that removes only the visible tumor, supramaximal resection aims to excise both the contrast-enhancing and non-contrast-enhancing parts of the tumor, potentially leading to better outcomes. This approach, sometimes referred to as FLAIRectomy, seeks to remove more of the tumor-affected brain tissue, which could reduce the chance of tumor recurrence and improve survival rates. By pushing the boundaries of how much tumor can be safely removed, researchers hope to offer glioma patients a more effective treatment option.
What evidence suggests that this trial's resection techniques could be effective for high-grade glioma?
This trial will compare two surgical approaches for brain tumor removal: supramaximal resection and maximal safe resection. Research has shown that removing more of a brain tumor, including parts not visible on certain scans, might extend the lives of patients with aggressive brain cancers. Studies have found that patients with more extensive tumor removal tend to survive longer. Specifically, for glioblastoma, a common type of brain cancer, this approach has been linked to survival times of up to 20–25 months. This method might also benefit patients with specific genetic types of brain tumors, such as IDH-mutant astrocytomas. Overall, the goal is to reduce tumor size as much as possible, potentially leading to a longer and better quality of life.678910
Who Is on the Research Team?
Jasper Gerritsen, MD PhD
Principal Investigator
Erasmus Medical Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Participants undergo either supramaximal or maximal safe resection of the tumor
Postoperative Evaluation
Participants are evaluated for neurological and functional outcomes using NIHSS, MOCA, and other assessments
Follow-up
Participants are monitored for safety, quality of life, and progression-free survival
Long-term Follow-up
Participants are monitored for overall survival and progression-free survival
What Are the Treatments Tested in This Trial?
Interventions
- Maximal safe resection
- Supramaximal resection
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Supramaximal resection: maximal resection of the contrast-enhancing and non-contrast-enhancing part of the tumor (FLAIRectomy)
Maximal safe resection of the contrast-enhancing part of the tumor
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jasper Gerritsen
Lead Sponsor
Massachusetts General Hospital
Collaborator
University Hospital Heidelberg
Collaborator
Insel Gruppe AG, University Hospital Bern
Collaborator
University of California, San Francisco
Collaborator
Technical University of Munich
Collaborator
Universitaire Ziekenhuizen KU Leuven
Collaborator
Haaglanden Medical Centre
Collaborator
Citations
Supramaximal Resection for Glioblastoma - PubMed Central
When gross total resection (GTR) is achieved, patient survival may extend to 20–25 months [2]. For glioma resection, including GBM, the goal is to achieve ...
Aggressive resection of non-contrast-enhanced tumor ...
Supramaximal nCE tumor resection enhances survival outcomes in glioblastoma, IDH-wildtype, but depending on clinical characteristics.
The SUPRAMAX Study: Supramaximal Resection Versus ...
A greater extent of resection of the contrast-enhancing (CE) tumor part has been associated with improved outcomes in high-grade glioma patients.
Impact of Supramaximal Resection on Survival - PMC
This intermediate profile may facilitate more effective tumor burden reduction during resection while retaining sufficient residual tumor cells ...
Maximal Extent of Resection, Including Supramaximal ...
Supratotal (ie, supramarginal, supracomplete, supramaximal) resections may improve outcomes for newly diagnosed glioblastoma and IDH-mutant astrocytomas.
Maximal Safe Resection in Glioblastoma Surgery
In 77.7% of the cases, the functional outcome improved or was stable over the pre-operative assessment. Combining multiple intraoperative imaging techniques ...
Outcomes of awake surgery for recurrent glioblastoma
The extent of resection ≥95 % was achieved in 75.6 %. •. Neurological deficits were observed in 4.9%. •. The median post-recurrence OS ...
Association of Maximal Extent of Resection With Survival ...
Maximal resection of contrast-enhanced plus non–contrast-enhanced tumor was found to be associated with increased overall survival in younger patients.
Maximal safe resection of diffuse lower grade gliomas ...
The mean extent of tumor resection was 94.6%. The mean tumor residue was 1.2 cm3. Only one patient (6.7%) experienced moderate late onset ...
The oncological role of resection in newly diagnosed ...
With a median overall survival of 5·6 years in region A, patients undergoing open resection due to presentation in region B had a longer survival of 10·2 years.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.