Surgery and Radiation vs. Radiation Alone for Brain Cancer
Recruiting in Palo Alto (17 mi)
+190 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: NRG Oncology
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 4 jurisdictions
Trial Summary
What is the purpose of this trial?This phase III trial compares the usual treatment of surgery after stereotactic radiosurgery (SRS) to receiving SRS before surgery in treating patients with cancer that has spread to the brain (brain metastases). Stereotactic radiosurgery is a type of radiation therapy that delivers a high dose of radiation to target tumors and minimizes effect on normal surrounding brain tissue. The combination of surgery and radiation may stop the tumor from growing for a few months or longer and may reduce symptoms of brain metastases. This study investigates whether treating with SRS before surgery may be better than SRS after surgery in reducing the possibility of the tumor coming back, reducing or preventing the cancer from spreading to other areas of the brain and reducing the risk of scarring on the brain from radiation.
How does the treatment of surgery and radiation differ from radiation alone for brain cancer?
The combination of surgery and radiation for brain cancer is unique because it often results in longer survival, fewer recurrences, and better quality of life compared to radiation alone. Surgery physically removes the tumor, which can be more effective in reducing cancer recurrence and improving outcomes when followed by radiation.
145610Is surgery and radiation for brain cancer generally safe for humans?
Surgery for brain tumors, including craniotomy, can have risks such as surgical site infections and other complications, but these are generally well-studied and managed. Radiation therapy, like Stereotactic Radiosurgery (SRS), is also commonly used and considered safe, though it may have specific risks depending on the patient's condition. Overall, both treatments have been used safely in humans, but individual risks can vary based on factors like the patient's health and the complexity of the surgery.
7891112What data supports the effectiveness of the treatment Surgery and Radiation vs. Radiation Alone for Brain Cancer?
Research shows that patients with a single brain metastasis who undergo surgery followed by radiation live longer, have fewer cancer recurrences in the brain, and maintain a better quality of life compared to those who receive only radiation.
123510Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that cytotoxic chemotherapy or tyrosine/multi-kinase inhibitors should not be taken within 3 days before, on the day of, or within 3 days after the completion of stereotactic radiosurgery (SRS).
Eligibility Criteria
This trial is for adults with 1-4 brain metastases, one needing surgery. Participants must have a lesion larger than 2cm but smaller than 5cm, not near the optic chiasm or in the brainstem, and be able to tolerate surgery and radiosurgery. They should agree to use contraception and not have had certain cancers or prior cranial radiotherapy.Inclusion Criteria
My brain metastases are not near the optic nerve or in the brainstem.
My untreated cancer spots are smaller than 4.0 cm.
The tumor to be removed is between 2.0 cm and 5.0 cm in size.
I am medically fit for surgery and stereotactic radiosurgery (SRS).
I am 18 years old or older.
Exclusion Criteria
I am scheduled for surgery to remove more than one brain tumor.
My cancer is either a germ cell tumor, small cell carcinoma, or lymphoma.
My cancer has spread to the lining of my brain and spinal cord.
I don't have health issues that make surgery or anesthesia too risky for me.
I have had radiation therapy to my brain.
Participant Groups
The study compares adding stereotactic radiosurgery (high-dose radiation targeting only cancer areas) before or after surgical removal of brain tumors. It aims to see which sequence is more effective at controlling tumor growth and reducing symptoms.
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (stereotactic radiosurgery, surgery)Experimental Treatment4 Interventions
Within 7 days before surgery, patients undergo stereotactic radiosurgery for 1 fraction. Patients undergo surgery per standard of care.
Group II: Arm I (surgery, stereotactic radiosurgery)Active Control4 Interventions
Patients undergo surgery per standard of care. Within 10-30 days after surgery, patients undergo stereotactic radiosurgery for 1 fraction.
Brain Surgery is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Brain Surgery for:
- Brain metastases
- Primary brain tumors
- Vascular malformations
🇺🇸 Approved in United States as Brain Surgery for:
- Brain metastases
- Primary brain tumors
- Epilepsy
- Trigeminal neuralgia
🇨🇦 Approved in Canada as Brain Surgery for:
- Brain metastases
- Primary brain tumors
- Vascular malformations
🇯🇵 Approved in Japan as Brain Surgery for:
- Brain metastases
- Primary brain tumors
- Epilepsy
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Carle on VermilionDanville, IL
Penn State Milton S Hershey Medical CenterHershey, PA
MGC Hematology Oncology-UnionUnion, SC
Montefiore Medical Center-Weiler HospitalBronx, NY
More Trial Locations
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Who is running the clinical trial?
NRG OncologyLead Sponsor
National Cancer Institute (NCI)Collaborator
References
A randomized trial of surgery in the treatment of single metastases to the brain. [2022]To assess the efficacy of surgical resection of brain metastases from extracranial primary cancer, we randomly assigned patients with a single brain metastasis to either surgical removal of the brain tumor followed by radiotherapy (surgical group) or needle biopsy and radiotherapy (radiation group). Forty-eight patients (25 in the surgical group and 23 in the radiation group) formed the study group; 6 other patients (11 percent) were excluded from the study because on biopsy their lesions proved to be either second primary tumors or inflammatory or infectious processes. Recurrence at the site of the original metastasis was less frequent in the surgical group than in the radiation group (5 of 25 [20 percent] vs. 12 of 23 [52 percent]; P less than 0.02). The overall length of survival was significantly longer in the surgical group (median, 40 weeks vs. 15 weeks in the radiation group; P less than 0.01), and the patients treated with surgery remained functionally independent longer (median, 38 weeks vs. 8 weeks in the radiation group; P less than 0.005). We conclude that patients with cancer and a single metastasis to the brain who receive treatment with surgical resection plus radiotherapy live longer, have fewer recurrences of cancer in the brain, and have a better quality of life than similar patients treated with radiotherapy alone.
The influence of surgery and radiation therapy on patients with brain metastases. [2019]The place for operation and for radiation therapy in the management of brain metastases is reviewed from the experience of 1895 patients treated in two studies of the Radiation Therapy Oncology Group. Operative removal may be of benefit to patients with solitary peripheral lesions in non-critical brain locations. Operation is also appropriate when the diagnosis is in doubt. Radiation therapy with appropriate steroid management is of benefit to patients with multiple metastases or where operative intervention is not reasonable. Short course low-dose treatment has been as beneficial as more aggressive prolonged radiation therapy.
Surgical treatment of solitary brain metastases: Monmouth County experience. [2004]Our experience in Monmouth County with surgical resection of single brain metastases followed by whole brain radiotherapy confirms the findings of a recent prospective randomized controlled study of this problem and demonstrates that patients treated with surgical resection followed by whole brain radiation live longer and have a better quality of life than those patients treated with radiotherapy alone. Best results are attainable if there is no evidence of disease activity at the primary site or systemically at the time the brain metastasis is diagnosed.
Surgery and radiotherapy compared with gamma knife radiosurgery in the treatment of solitary cerebral metastases of small diameter. [2006]The aim of this retrospective study was to compare treatment results of surgery plus whole-brain radiation therapy (WBRT) with gamma knife radiosurgery alone as the primary treatment for solitary cerebral metastases suitable for radiosurgical treatment.
Neurosurgical management of brain tumors. [2012]The combination of surgery and radiation remains the most effective treatment for tumors affecting the central nervous system. This article reviews surgical therapy for brain tumors. Special attention is paid to new approaches to brain tumor therapy and to the interaction between neuroimaging and successful surgery.
Stereotactic radiosurgery in the management of brain metastasis. [2022]Metastatic disease to the brain occurs in a significant percentage of patients with cancer and can limit survival and worsen quality of life. Glucocorticoids and whole-brain radiation therapy (WBRT) have been the mainstay of intracranial treatments, while craniotomy for tumor resection has been the standard local therapy. In the last few years however, stereotactic radiosurgery (SRS) has emerged as an alternative form of local therapy. Studies completed over the past decade have helped to define the role of SRS. The authors review the evolution of the techniques used and the indications for SRS use to treat brain metastases. Stereotactic radiosurgery, compared with craniotomy, is a powerful local treatment modality especially useful for small, multiple, and deep metastases, and it is usually combined with WBRT for better regional control.
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.
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.
Defining a new neurosurgical complication classification: lessons learned from a monthly Morbidity and Mortality conference. [2019]OBJECTIVEThe absence of a commonly accepted standardized classification system for complication reporting confounds the recognition, objective reporting, management, and avoidance of perioperative adverse events. In the past decade, several classification systems have been proposed for use in neurosurgery, but these generally focus on tallying specific complications and grading their effect on patient morbidity. Herein, the authors propose and prospectively validate a new neurosurgical complication classification based on understanding the underlying causes of the adverse events.METHODSA new complication classification system was devised based on the authors' previous work on morbidity in endovascular surgery. Adverse events were prospectively compiled for all neurosurgical procedures performed at their tertiary care academic medical center over the course of 1 year into 5 subgroups: 1) indication errors; 2) procedural errors; 3) technical errors; 4) judgment errors; and 5) critical events. The complications were presented at the monthly institutional Morbidity and Mortality conference where, following extensive discussion, they were assigned to one of the 5 subgroups. Additional subgroup analyses by neurosurgical subspecialty were also performed.RESULTSA total of 115 neurosurgical complications were observed and analyzed during the study period. Of these, nearly half were critical events, while technical errors accounted for approximately one-third of all complications. Within neurosurgical subspecialties, vascular neurosurgery (36.5%) had the most complications, followed by spine & peripheral nerve (21.7%), neuro-oncology (14.8%), cranial trauma (13.9%), general neurosurgery (12.2%), and functional neurosurgery (0.9%).CONCLUSIONSThe authors' novel neurosurgical complication classification system was successfully implemented in a prospective manner at their high-volume tertiary medical center. By employing the well-established Morbidity and Mortality conference mechanism, this simple system may be easily applied at other neurosurgical centers and may allow for uniform analyses of perioperative morbidity and the introduction of corrective initiatives.
Role of Radiosurgery in the Treatment of Brain Metastasis. [2020]Craniotomy and stereotactic radiosurgery seem to be similarly effective and appropriate choices for the treatment of patients with favorable prognostic factors and limited brain metastases.
Comorbidity Burden and Presence of Multiple Intracranial Lesions Are Associated with Adverse Events after Surgical Treatment of Patients with Brain Metastases. [2020]Surgical resection is a key treatment modality for brain metastasis (BM). However, peri- and postoperative adverse events (PAEs) might be associated with a detrimental impact on postoperative outcome. We retrospectively analyzed our institutional database with regard to patient safety indicators (PSIs), hospital-acquired conditions (HACs) and specific cranial surgery-related complications (CSCs) as high-quality metric profiles for PAEs in patients who had undergone surgery for BM in our department between 2013 and 2018. The comorbidity burden was assessed by means of the Charlson comorbidity index (CCI). A multivariate analysis was performed to identify independent predictors for the development of PAEs after surgical resection of BM. In total, 33 patients (8.5%) suffered from PAEs after surgery for BM. Of those, 17 PSI, 5 HAC and 11 CSC events were identified. Multiple brain metastases (p = 0.02) and a higher comorbidity burden (CCI > 10; p = 0.003) were associated with PAEs. In-hospital mortality of patients suffering from a PAE was significantly higher than that of patients without a PAE (24% vs. 0.6%; p < 0.0001). Awareness of risk factors for postoperative complications enables future prevention and optimal response, particularly in vulnerable oncological patients. The present study identified the presence of multiple brain metastases and increased comorbidity burden associated with PAEs in patients suffering from BM.
Surgical Site Infections in Glioblastoma Patients-A Retrospective Analysis. [2023]Surgical site infections (SSIs) after craniotomy lead to additional morbidity and mortality for patients, which are related to higher costs for the healthcare system. Furthermore, SSIs are associated with a longer hospital stay for the patient, which is particularly detrimental in glioblastoma patients due to their limited life expectancy. Risk factors for SSIs have already been described for craniotomies in general. However, there is limited data available for glioblastoma patients. As postoperative radiation influences wound healing, very early radiation is suspected to be a risk factor for SSI. Nevertheless, there are no data on the optimal timing of radiotherapy. To define risk factors for these patients, we analyzed our collective. We performed a retrospective analysis of all operations with histological evidence of a glioblastoma between 2012 and 2021. Open biopsy and tumor removal (gross total resection, subtotal resection) were included. Stereotactic biopsies were excluded. Demographic data such as age and gender, as well as duration of surgery, diameter of the trepanation, postoperative radiation with interval, postoperative chemotherapy, highest blood glucose level, previous surgery, ASA score, foreign material introduced, subgaleal suction drainage, ventricle opening and length of hospital stay, were recorded. The need for surgical revision due to infection was registered as an SSI. A total of 177 patients were included, of which 14 patients (7.9%) suffered an SSI. These occurred after a median of 45 days. The group with SSIs tended to include more men (57.1%, p = 0.163) and more pre-operated patients (50%, p = 0.125). In addition, foreign material and subgaleal suction drains had been implanted more frequently and the ventricles had been opened more frequently, without reaching statistical significance. Surprisingly, significantly more patients without SSIs had been irradiated (80.3%, p = 0.03). The results enable a better risk assessment of SSIs in glioblastoma patients. Patients with previous surgery, introduced foreign material, subgaleal suction drain and opening of the ventricle may have a slightly higher for SSIs. However, because none of these factors were significant, we should not call them risk factors. A less radical approach to surgery potentially involving these factors is not justified. The postulated negative role of irradiation was not confirmed, hence a rapid chemoradiation should be induced to achieve the best possible oncologic outcome.