Early Brain Surgery for Brain Tumor

Recruiting in Palo Alto (17 mi)

Overseen by Terry C. Burns, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Mayo Clinic

Must not be taking: Avastin

Disqualifiers: Age < 18, Pregnant, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This clinical trial evaluates the side effects and possible benefits of operating on brain tumors prior to the tumor coming back (recurrence). Understanding when surgery is most useful to patients with brain tumors is important. Some patients may undergo chemotherapy or radiation but still have visible tumor remaining after treatment. The purpose of this research is to compare outcomes of those who have surgery after chemotherapy or radiation, but prior to tumor recurrence, to those who have surgery at a different time, or no surgery at all.

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 data supports the effectiveness of the treatment 'Early Brain Surgery for Brain Tumor'?

Research shows that performing brain surgery, like awake craniotomy, can help remove more of the tumor while keeping brain function intact, which is linked to longer survival in patients with brain tumors. ^{1 2 3 4 5}

Is early brain surgery for brain tumors generally safe for humans?

Research on brain surgery, including craniotomy and neurosurgery for brain tumors, shows that while it is a high-risk procedure, efforts are being made to improve safety and reduce complications. Studies have reviewed adverse events and complications, indicating that while risks exist, understanding and managing these risks is a focus in the field. ^{5 6 7 8 9}

How does early brain surgery for brain tumor differ from other treatments?

Early brain surgery for brain tumors, particularly using awake craniotomy, allows surgeons to perform the procedure while the patient is awake, enabling real-time communication to minimize the risk of damaging critical brain areas. This approach can lead to more precise tumor removal and potentially better outcomes compared to traditional methods where the patient is fully anesthetized. ^{3 10 11 12 13}

Research Team

Terry C. Burns, MD, PhD

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

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 am 18 years old or older.

I have had chemotherapy or radiation for my tumor.

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.

Trial Timeline

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

Treatment Details

Interventions

• Brain Surgery (Procedure)

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.

Participant Groups

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+

Dr. Gianrico Farrugia

Mayo Clinic

Chief Executive Officer since 2019

MD from University of Malta Medical School

Dr. Richard Afable

Mayo Clinic

Chief Medical Officer

MD from Loyola Stritch School of Medicine

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

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 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]

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 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]

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 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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Awake glioma surgery: technical evolution and nuances. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Perioperative Care and Outcomes of Patients with Brain Tumors Undergoing Elective Craniotomy: Experience from an Ethiopian Tertiary-Care Hospital. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical outcomes from maximum-safe resection of primary and metastatic brain tumors using awake craniotomy. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Reoperation for brain metastases. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Surgical mortality and selected complications in 273 consecutive craniotomies for intracranial tumors in pediatric patients. [2012]

6. Italy pubmed.ncbi.nlm.nih.gov

Intra- and postoperative adverse events in awake craniotomy for intrinsic supratentorial brain tumors. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Patterns in neurosurgical adverse events: intracranial neoplasm surgery. [2012]

8. United States pubmed.ncbi.nlm.nih.gov

Neurosurgical outcomes in a modern series of 400 craniotomies for treatment of parenchymal tumors. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Perioperative Factors Affecting Readmission After Awake Craniotomy: Analysis of 609 Consecutive Cases. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Development of a safe and pragmatic awake craniotomy program at Maine Medical Center. [2011]

11. United States pubmed.ncbi.nlm.nih.gov

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

12. Austria pubmed.ncbi.nlm.nih.gov

Awake Craniotomy for Tumor Resection: Further Optimizing Therapy of Brain Tumors. [2022]

13. France pubmed.ncbi.nlm.nih.gov

[Cerebral metastases. A study of a surgical series of 81 cases]. [2006]