Palliative Care vs Surgery for Brain Cancer
(PALSUR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the best treatment options for individuals with high-grade glioma, an aggressive brain tumor. It compares three approaches: palliative care (supportive care without surgery), tumor biopsy, and tumor resection (surgical removal). The goal is to determine which treatment extends patients' lives and enhances their quality of life. Suitable candidates are those diagnosed with high-grade glioma via MRI and able to provide written consent. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants the opportunity to contribute to significant findings.
Do I need to stop my current medications for the 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?
Studies of tumor removal surgery suggest it can be performed safely when the tumor is carefully selected. Researchers have found that while complication rates vary, the surgery is generally safe when skilled surgeons perform it. For instance, surgeries conducted by resident doctors under supervision have proven safe. Some studies also indicate that patients can achieve good outcomes from tumor removal, sometimes even matching the survival rates of the general population.
Tumor biopsy is generally considered a low-risk procedure. It involves taking a small sample of tumor tissue to better understand its type. This procedure is usually well-tolerated, with only minor risks such as bleeding or infection.
In this study, some patients receive palliative care, which focuses on improving quality of life without surgery. This approach does not treat the tumor itself but aims to manage symptoms and provide comfort.
Overall, both tumor removal and biopsy have safety records that support their use in medical care, though they come with some risks. Palliative care, on the other hand, avoids surgical risks and focuses on symptom relief.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to compare different approaches for managing high-grade glioma, a particularly aggressive brain cancer. Unlike the standard care options, which often include surgical resection as a primary approach, this trial investigates whether palliative care alone can be as effective. Palliative care focuses on providing the best supportive care without surgery, which could offer significant quality-of-life benefits to patients by avoiding the risks and recovery time associated with surgery. Additionally, the trial examines tumor biopsy and maximal safe tumor resection, allowing researchers to better understand the outcomes of each method. This exploration could lead to more personalized treatment strategies that align more closely with patients' needs and preferences.
What evidence suggests that this trial's treatments could be effective for high-grade glioma?
Research has shown that removing as much of the tumor as possible, known as tumor resection, is linked to better survival rates in patients with high-grade glioma. Studies have found that patients who have most of their tumor removed tend to live longer, especially when both the visible and hidden parts of the tumor are excised. In some cases, up to 77.7% of patients experienced stable or improved function after surgery. For suitable candidates, surgery could extend life and maintain quality of life.
In this trial, participants may be assigned to different treatment arms. One arm involves tumor resection, focusing on maximal safe removal of the tumor. Another arm involves palliative care, which emphasizes comfort and quality of life without surgery. Additionally, a tumor biopsy arm involves taking a small sample to better understand the tumor, aiding in planning further treatments.678910Who 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
Treatment
Participants receive either palliative care, biopsy, or resection
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Overall survival and quality of life are assessed up to 5 years
What Are the Treatments Tested in This Trial?
Interventions
- Palliative Care
- Tumor biopsy
- Tumor resection
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Maximal safe resection of the tumor
Tumor biopsy
Best supportive care without surgical intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jasper Gerritsen
Lead Sponsor
University of California, San Francisco
Collaborator
Universitaire Ziekenhuizen KU Leuven
Collaborator
Haaglanden Medical Centre
Collaborator
University Hospital Heidelberg
Collaborator
Technical University of Munich
Collaborator
Massachusetts General Hospital
Collaborator
Insel Gruppe AG, University Hospital Bern
Collaborator
Citations
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 ...
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.
Aggressive resection of non-contrast-enhanced tumor ...
Supramaximal nCE tumor resection enhances survival outcomes in glioblastoma, IDH-wildtype, but depending on clinical characteristics.
Improving maximal safe brain tumor resection with ...
In considering surgical tumor resection, suboptimal extent of resection is linked to poor clinical outcomes and lower overall survival rates.
Maximal safe resection of diffuse lower grade gliomas ...
Individuals with at least 90% EOR achieved 5-year survival rates of 97%, while patients with less than 90% EOR achieved 5-year survival rates of ...
Safety and risk analysis of total resection surgery ...
Despite these advancements, surgical outcomes remain variable, with complication rates reported between 46.2% and 86.7% for spinal tumor ...
Safety of resident training in the microsurgical resection ...
These results suggest that microsurgical resection of carefully selected intracranial tumors can be performed safely by supervised neurosurgical residents.
The impact of tumor resection on survival and functional ...
This study aimed to clarify the impact of tumor resection on survival and functional outcomes, and to identify subgroups benefiting from resection.
9.
consultqd.clevelandclinic.org
consultqd.clevelandclinic.org/excellent-outcomes-achievable-with-surgical-resection-of-benign-cardiac-tumorsOutcomes of Surgical Resection of Benign Cardiac Tumors
Patients can expect survival rates comparable to the general U.S. population, finds a large database study from Cleveland Clinic.
Safety and long-term prognosis of simultaneous versus staged ...
Simultaneous resection is safe and effective for SCLM patients. The long-term prognosis is equivalent to that of the traditional staged resection.
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