Early Brain Surgery for Brain Tumor

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Avastin

Disqualifiers: Age < 18, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effects of brain surgery for individuals with brain tumors, particularly following chemotherapy or radiation. It seeks to determine if surgery before tumor recurrence leads to better outcomes than waiting or not having surgery. The trial focuses on those with visible tumor remnants after initial treatments. Individuals who have undergone prior treatments and still have visible tumor parts may consider participating.

As an unphased study, this trial provides a unique opportunity to contribute to medical knowledge and potentially enhance future treatment strategies.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have taken Avastin in the past 6 months, you cannot participate in this trial.

What prior data suggests that brain surgery is safe for patients with brain tumors?

Research has shown that brain surgery to remove tumors carries some risks. In a study of over 16,500 patients, about 3.4% experienced complications, such as infections or difficulties with movement or speech. Another study found that hospitals in South Korea with higher surgery volumes had better survival rates within a year.

Complications from surgery were sometimes temporary, affecting about 19.2% of patients, while permanent issues occurred in about 10.6% of cases. Evidence also indicates that with careful patient selection, some individuals can safely return home the same day after surgery.

Although surgery involves risks, data suggests that, under the right conditions, it can be safely performed for many patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about early brain surgery for brain tumors because it could offer a more proactive approach compared to traditional wait-and-see or medication-based treatments, like chemotherapy and radiation. Unlike those options, which often act after the tumor has grown or spread, early surgery aims to remove the tumor promptly, potentially preventing further complications and improving outcomes. This approach focuses on immediate physical removal, which could reduce the tumor's impact on brain function more quickly than other treatments that require time to shrink the tumor.

What evidence suggests that early brain surgery might be an effective treatment for brain tumors?

Research has shown that brain surgery, which participants in this trial will undergo, can significantly improve the quality of life and survival for people with brain tumors. The main goal is to remove as much of the tumor as possible without harming normal brain tissue. Advances in medical technology have made these surgeries more effective and safer. Studies have found that patients who undergo brain surgery often experience better outcomes, especially when combined with treatments like chemotherapy or radiation. This evidence suggests that surgery might be beneficial even before a tumor returns, allowing patients to live longer and feel better. ^{6 7 8 9 10}

Who Is on the Research Team?

Terry C. Burns, MD, PhD

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had chemo or radiation for brain tumors but still have some tumor left. They must be willing to undergo surgery, not be pregnant or unable to consent, and can't have had a complete tumor removal before. They should also not qualify for other clinical trials.

Inclusion Criteria

My brain tumor diagnosis was confirmed through lab tests or imaging.

I have had chemotherapy or radiation for my tumor.

Enrollment in the Mayo Clinic Cancer Center Neuro-Oncology Program Registry for the study of Nervous System Tumors (IRB#12-003458)

Exclusion Criteria

I am considered at high risk for surgery complications by my surgeon.

I had surgery to completely remove a brain tumor, and no visible disease remains.

I have not taken Avastin in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Patients undergo surgery as indicated clinically when applicable

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery

6 months

2 visits (in-person) at 3 and 6 months, then every 6 months thereafter

Long-term follow-up

Participants are monitored for long-term outcomes such as local recurrence and overall survival

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Brain Surgery

Trial Overview

The study looks at the timing of brain surgery in treating tumors that haven't recurred yet. It compares outcomes between those having early surgery after chemo/radiation and those who wait or don’t get operated on at all.

How Is the Trial Designed?

Group I: Treatment (surgery) Experimental Treatment 1 Intervention

Patients undergo surgery as indicated clinically when applicable.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 273 craniotomies performed on pediatric patients for brain tumors, the surgical mortality rate was very low at 0.4%, indicating a high level of safety for this procedure.

Complication rates were also low, with significant issues like meningitis occurring in only 1.8% of cases and most patients (87.2%) experiencing no change or improvement in neurological function post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical mortality and selected complications in 273 consecutive craniotomies for intracranial tumors in pediatric patients. Lassen, B., Helseth, E., Egge, A., et al.[2012]

In a study of 21 patients undergoing repeat surgery for recurrent brain metastases, median survival after the second craniotomy was 9 months, with a 25% chance of surviving for 2 years.

Two-thirds of the patients experienced neurological improvement post-surgery, with no reported mortality and only one case of increased neurological deficit, suggesting that repeat resection can be a safe and effective option for selected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reoperation for brain metastases. Sundaresan, N., Sachdev, VP., DiGiacinto, GV., et al.[2017]

Awake craniotomy can be safely and effectively performed in a community hospital setting, with 80% of patients achieving gross total resection of glial tumors and a low rate of postoperative complications (only 2 out of 25 patients experienced new deficits).

The streamlined anesthetic protocol, primarily using midazolam, fentanyl, propofol, and local anesthetic, resulted in an average operative time of 159 minutes and a hospital stay of 3.7 days, demonstrating efficiency in the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a safe and pragmatic awake craniotomy program at Maine Medical Center. Rughani, AI., Rintel, T., Desai, R., et al.[2011]

Classic craniotomy for brain tumor biopsy or resection typically requires large skin flaps and openings to ensure accurate localization of subcortical tumors, which can be invasive.

Traditional localization methods used in classic resections are often qualitative and imprecise, potentially impacting the effectiveness and safety of the surgical procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-assisted volumetric stereotactic neurosurgery: present methodology and future directions. Kelly, PJ.[2011]

Awake craniotomy has been performed on 219 patients with gliomas since 1994, allowing for radical tumor resection while minimizing the risk of postoperative neurological deficits through continuous communication between the patient and surgeon.

The integration of intraoperative high-field MRI since 2005 has enhanced the surgical protocol, helping to better define the relationship between the tumor and critical brain areas, which is crucial for optimizing patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Awake Craniotomy for Tumor Resection: Further Optimizing Therapy of Brain Tumors. Mehdorn, HM., Schwartz, F., Becker, J.[2022]

The review of cranial tumor surgeries revealed that complication rates can range from 9% to 40%, with deep venous thromboembolism (DVT) being the most common adverse event, occurring in 3% to 26% of cases.

Implementing standardized safety protocols, such as DVT prophylaxis and intraoperative navigation techniques, could potentially reduce the incidence of adverse events and improve patient outcomes in neurosurgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns in neurosurgical adverse events: intracranial neoplasm surgery. Wong, JM., Panchmatia, JR., Ziewacz, JE., et al.[2012]

In a study of 153 patients undergoing craniotomy for brain tumor resection in Ethiopia, factors such as tumor location, preoperative hydrocephalus, and lower blood loss were associated with better extubation outcomes, indicating their importance in perioperative care.

Postoperative complications like obstructive hydrocephalus, surgical site infections, and pneumonia occurred in about 10% of patients, emphasizing the need for careful monitoring and management after surgery to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative Care and Outcomes of Patients with Brain Tumors Undergoing Elective Craniotomy: Experience from an Ethiopian Tertiary-Care Hospital. Abate Shiferaw, A., Negash, AY., Tirsit, A., et al.[2023]

In a study of 76 patients undergoing awake craniotomies for brain tumor resection, 59% achieved gross total resection, indicating high efficacy in tumor removal while preserving critical brain functions.

The procedure was associated with a short average hospital stay of 1.7 days, with 75% of patients discharged within 24 hours, and a low rate of postoperative complications, as 67% of patients showed improvement in neurological status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes from maximum-safe resection of primary and metastatic brain tumors using awake craniotomy. Groshev, A., Padalia, D., Patel, S., et al.[2022]

In a study of 81 patients undergoing craniotomy for brain metastasis, the overall surgical mortality rate was 7.4%, and 58% of patients experienced excellent postoperative recovery, indicating a relatively safe surgical intervention with a significant proportion of patients recovering well.

The mean survival after surgery was 10.2 months, with some patients surviving over 18 months, suggesting that surgical intervention can provide meaningful survival benefits regardless of the primary cancer type.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cerebral metastases. A study of a surgical series of 81 cases]. Delarive, J., de Tribolet, N.[2006]

In a study of 25 patients undergoing awake craniotomy for brain tumors, 92% experienced surgery-related inconveniences, with intraoperative hypertension being the most common issue (32%).

Postoperatively, 68% of patients faced adverse events, primarily new language deficits (40%) and motor deficits (36%), highlighting significant risks associated with this surgical approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra- and postoperative adverse events in awake craniotomy for intrinsic supratentorial brain tumors. Kwinta, BM., Myszka, AM., Bigaj, MM., et al.[2021]

In a study of 327 patients undergoing 400 craniotomies for brain tumor removal, the major complication rate was 13%, with a low operative mortality rate of 1.7%, indicating that these surgeries can be performed with a relatively low risk of severe outcomes.

Patients with tumors located in eloquent brain regions experienced more neurological deficits, but gross total resection in these areas did not lead to increased major neurological impairments, suggesting that surgery can be safely performed even in complex cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurosurgical outcomes in a modern series of 400 craniotomies for treatment of parenchymal tumors. Sawaya, R., Hammoud, M., Schoppa, D., et al.[2023]

In a study of 609 awake craniotomy surgeries, 6.0% of patients were readmitted within 30 days post-surgery, primarily due to neurologic decline, surgical site infections, and seizures, highlighting the need for careful monitoring after discharge.

Patients with a preoperative history of seizures and those requiring reoperation due to complications like infection or hemorrhage were at a higher risk for readmission, indicating that these factors should be closely managed in the postoperative care plan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative Factors Affecting Readmission After Awake Craniotomy: Analysis of 609 Consecutive Cases. Takami, H., Venkatraghavan, L., Bernstein, M.[2022]

Awake craniotomy has become the gold standard for safely maximizing tumor resection in glioma patients, particularly those with tumors near critical brain areas, due to its ability to preserve neurological function.

The technique is associated with an extremely low rate of complications, making it a highly effective option for improving patient outcomes in terms of both functional and oncological results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Awake glioma surgery: technical evolution and nuances. Gogos, AJ., Young, JS., Morshed, RA., et al.[2021]

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