Early Brain Surgery for Brain Tumor
Recruiting in Palo Alto (17 mi)
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.
12345Is 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.
56789How 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.
310111213Eligibility 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.
+4 more
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.
+3 more
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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Treatment (surgery)Experimental Treatment1 Intervention
Patients undergo surgery as indicated clinically when applicable.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo Clinic in RochesterRochester, MN
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Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Awake glioma surgery: technical evolution and nuances. [2021]Multiple studies have demonstrated that improved extent of resection is associated with longer overall survival for patients with both high and low grade glioma. Awake craniotomy was developed as a technique for maximizing resection whilst preserving neurological function.
Perioperative Care and Outcomes of Patients with Brain Tumors Undergoing Elective Craniotomy: Experience from an Ethiopian Tertiary-Care Hospital. [2023]To describe patients, perioperative care, and outcomes undergoing supratentorial and infratentorial craniotomy for brain tumor resection in a tertiary-care hospital in Ethiopia.
Clinical outcomes from maximum-safe resection of primary and metastatic brain tumors using awake craniotomy. [2022]To retrospectively analyze outcomes in patients undergoing awake craniotomies for tumor resection at our institution in terms of extent of resection, functional preservation and length of hospital stay.
Reoperation for brain metastases. [2017]We report the results of reoperation for brain metastases in 21 patients with recurrent tumors following initial successful resection. The tumor recurrences were local (original site) in 14 patients, and occurred at other sites in the brain in the remaining seven. Time to CNS recurrence ranged from 3 to 30 months. At time of repeat craniotomy, disease was limited to the CNS in 12 (57%) of the patients. Median survival following second craniotomy was 9 months, and the actuarial 2-year survival was 25%. Neurological improvement was seen in two thirds of the patients; the median duration of neurological improvement was 6 months. There was no mortality, and only one patient developed increased deficit following surgery. We conclude that repeat resection of brain metastases is an important therapeutic option in selected patients, and should be considered in symptomatic patients with accessible mass lesions before the use of other experimental treatment.
Surgical mortality and selected complications in 273 consecutive craniotomies for intracranial tumors in pediatric patients. [2012]In order to weigh the risks of surgery against the presumed advantages, it is important to have specific knowledge about complication rates. Contemporary reports on complications following craniotomy for tumor resection in pediatric patients are scarce.
Intra- and postoperative adverse events in awake craniotomy for intrinsic supratentorial brain tumors. [2021]To determine the frequency and consequences of intra- and postoperative adverse events in awake craniotomy for intrinsic supratentorial brain tumors. Despite the growing prevalence of awake craniotomy intra- and postoperative, adverse events related to this surgery are poorly discussed.
Patterns in neurosurgical adverse events: intracranial neoplasm surgery. [2012]Neurosurgery is a high-risk specialty currently undertaking the pursuit of systematic approaches to measuring and improving outcomes. As part of a project to devise evidence-based safety interventions for specialty surgery, the authors sought to review current evidence in cranial tumor resection concerning the frequency of adverse events in practice, their patterns, and current methods of reducing the occurrence of these events. This review represents part of a series of papers written to consolidate information about these events and preventive measures as part of an ongoing effort to ascertain the utility of devising system-wide policies and safety tools to improve neurosurgical practice.
Neurosurgical outcomes in a modern series of 400 craniotomies for treatment of parenchymal tumors. [2023]The goals were to critically review all complications resulting within 30 days after craniotomies performed for excision of intra-axial brain tumors relative to factors likely to affect complication rates and to assess the value of these data in predicting the risk of surgical morbidity, particularly for surgery in eloquent brain regions.
Perioperative Factors Affecting Readmission After Awake Craniotomy: Analysis of 609 Consecutive Cases. [2022]Awake craniotomy is being used widely for tumors near eloquent areas of the brain and also to facilitate early discharge from the hospital. Although most of the complications occur early in the postoperative period, there is a certain risk of delayed postoperative adverse events after discharge. This study investigated the incidence and the risk factors for postdischarge readmission after awake surgeries.
Development of a safe and pragmatic awake craniotomy program at Maine Medical Center. [2011]Awake craniotomy offers an excellent means of performing intraoperative mapping and optimizing surgical resection of brain tumors. Awake craniotomy relies on a strong collaboration between anesthesiologists, neurosurgeons, and operating room staff. The authors recently introduced awake craniotomy for tumor resection at the Maine Medical Center and propose that it can be performed safely, effectively, and efficiently in a high-volume community hospital.
Computer-assisted volumetric stereotactic neurosurgery: present methodology and future directions. [2011]Classic craniotomy for biopsy or resection of intra-axial brain tumors usually employed large skin flaps and craniotomy openings. These were necessary so that surgeons could be certain that a subcortical tumor could be localized and that the extent of the lesion lay somewhere beneath and within the limits of the craniotomy. Localization methods for classic resection methods were qualitative and imprecise.
Awake Craniotomy for Tumor Resection: Further Optimizing Therapy of Brain Tumors. [2022]In recent years more and more data have emerged linking the most radical resection to prolonged survival in patients harboring brain tumors. Since total tumor resection could increase postoperative morbidity, many methods have been suggested to reduce the risk of postoperative neurological deficits: awake craniotomy with the possibility of continuous patient-surgeon communication is one of the possibilities of finding out how radical a tumor resection can possibly be without causing permanent harm to the patient.In 1994 we started to perform awake craniotomy for glioma resection. In 2005 the use of intraoperative high-field magnetic resonance imaging (MRI) was included in the standard tumor therapy protocol. Here we review our experience in performing awake surgery for gliomas, gained in 219 patients.Patient selection by the operating surgeon and a neuropsychologist is of primary importance: the patient should feel as if they are part of the surgical team fighting against the tumor. The patient will undergo extensive neuropsychological testing, functional MRI, and fiber tractography in order to define the relationship between the tumor and the functionally relevant brain areas. Attention needs to be given at which particular time during surgery the intraoperative MRI is performed. Results from part of our series (without and with ioMRI scan) are presented.
[Cerebral metastases. A study of a surgical series of 81 cases]. [2006]In this retrospective study, 81 patients operated by craniotomy for a brain metastasis are reviewed. Mean age is 56.3 years and most of the patients are male (71.6%). Clinically, 79% of the patients present a focal semiology, most frequently with neuropsychologic disturbances (43%); epilepsy is found in 31% of the cases. Symptoms related to intracranial hypertension (vomiting and headache) are present in 43% of the patients. On C.T.-scan, there is a solitary metastasis in 89% and the most common intracranial location is the frontal lobe (33.3%). The most frequent primary neoplasms are: bronchial adenocarcinoma in 19%, squamous carcinoma of the lung in 11%, melanoma in 12% and unknown origin in 18%. The surgical removal (as judged by the surgeon) is total in 70%, subtotal in 19% and partial in 11%. Standard operative mortality (30 days after craniotomy) is 7.4%. The postoperative course (till the patients leave our department) is excellent in 58% (complete neurologic recovery), steady in 20% (stability of symptoms and neurologic examination) and bad in 22%, with worsening of the neurological deficits. Most of the patients (84% of the patients who survive more than 30 days after the craniotomy) had postoperative whole brain radiotherapy with a hypofractionned schedule (total doses of 15 to 40 Gy with fractions of 200 to 650 cGy). Ten patients had surgery alone. Mean survival is 10.2 months with a follow-up of 12 months to 10 years. Ten patients survived over 18 months and one is still alive almost 4 years after his craniotomy. In this study, the survival is not modified by the primary lesion's histology.(ABSTRACT TRUNCATED AT 250 WORDS)