What side effects are associated with this type of intervention?

The most common treatments for Glioblastoma include surgery, radiation therapy, and chemotherapy. Repeat surgery (re-resection) can lead to risks such as infection, bleeding, and neurological deficits due to the complexity of brain surgery. Radiation therapy often results in side effects like fatigue, hair loss, and skin changes at the treatment site, and can also cause long-term effects such as cognitive decline and radiation necrosis. Chemotherapy, particularly with agents like temozolomide, can cause nausea, vomiting, fatigue, and myelosuppression, which increases the risk of infections. These treatments aim to improve survival and quality of life but come with significant side effects that need to be managed carefully.

What prior FDA approvals exist?

The FDA has approved several treatments for glioblastoma, including temozolomide, which is often used in conjunction with surgery and radiation therapy. Temozolomide is an oral chemotherapy drug that has shown efficacy in extending survival when used alongside radiotherapy. Bevacizumab, an anti-VEGF monoclonal antibody, has also been approved for recurrent glioblastoma due to its ability to reduce tumor-associated edema and improve quality of life. While there is no Level 1 evidence supporting repeat surgery (re-resection) for recurrent glioblastoma, observational studies suggest it may improve survival and quality of life, often in combination with these FDA-approved therapies.

What other types of research exist?

Promising novel alternatives to repeat surgery for glioblastoma patients include: 1) Targeted therapies such as bevacizumab, which inhibits angiogenesis; 2) Immunotherapies like checkpoint inhibitors (e.g., nivolumab) and CAR-T cell therapy; 3) Advanced radiation techniques such as magnetic resonance-guided laser ablation and stereotactic radiosurgery. These options aim to improve survival and quality of life by targeting tumor cells more precisely and enhancing the body's immune response against cancer.

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Repeat Surgery for Recurrent Glioblastoma

N/A

Recruiting

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

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

Must have

Previously histologically confirmed and surgically resected Glioblastoma

Previous craniotomy for open tumor resection (needle biopsies alone do not count as resection)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up follow-up for 5 years or until death

Awards & highlights

Summary

This trial is important because it will help neurosurgeons manage patients with recurrent GBM in the best way possible.

Who is the study for?

This trial is for adults over 18 with recurrent Glioblastoma (GBM) who've had it surgically removed before. Candidates should be considered by their surgeon to potentially benefit in quality of life from another surgery. Those unable to give informed consent are excluded.Check my eligibility

What is being tested?

The study tests the effectiveness of repeat surgical resection on patients with recurrent GBM, aiming to see if a second surgery can extend overall survival and improve time spent out of hospitals or care facilities without extra risks beyond standard care.See study design

What are the potential side effects?

Since the intervention involves routine surgical procedures, potential side effects include typical surgical risks such as infection, bleeding, neurological deficits depending on tumor location, and general anesthesia complications.

Eligibility Criteria

Inclusion Criteria

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

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My glioblastoma was confirmed by a biopsy and has been surgically removed.

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I have had brain surgery to remove a tumor.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ follow-up for 5 years or until death

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~follow-up for 5 years or until death

This trial's timeline: 3 weeks for screening, Varies for treatment, and follow-up for 5 years or until death for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Length of Overall Survival

Secondary outcome measures

Discharge to a location other than home

Aphasia

Incidence of peri-operative non-neurological complications (wound infection, CSF leaks)

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Repeat Surgical ResectionExperimental Treatment1 Intervention

Standard surgical operative management according to local practices.

Group II: Management Without Re-operationActive Control1 Intervention

Non-surgical management with standard care according to local practices.

0 / 3Eligibility 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

The primary treatments for Glioblastoma include surgical resection, radiation therapy, and chemotherapy. Surgical resection aims to remove as much of the tumor as possible, which can alleviate symptoms and improve survival. Radiation therapy uses high-energy beams to kill cancer cells and shrink tumors, targeting residual cells post-surgery. Chemotherapy, often with the drug temozolomide, works by damaging the DNA of cancer cells, preventing their replication. For recurrent GBM, repeat surgery (re-resection) may be considered to further reduce tumor burden and potentially improve survival and quality of life. These treatments are crucial as they address the aggressive nature of GBM, aiming to prolong survival and maintain neurological function.