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Dose-staged Gamma Knife Radiosurgery Versus Microsurgical Resection

Dose-staged Gamma Knife Radiosurgery Versus Microsurgical Resection - Evaluation of Neurosurgical Treatment Methods for Patients With Larger Brain Metastases - an Explorative Prospective Study

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04857905
Enrollment
100
Registered
2021-04-23
Start date
2020-07-01
Completion date
2025-12-01
Last updated
2024-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Metastases

Keywords

Gamma Knife Radiosurgery, Brain metastases, Microsurgical resection

Brief summary

Background. Brain metastases (BM) are the most common intracranial tumor and occur in 20-40% of all oncological patients. The most common primary cancer in brain metastases is lung cancer, followed by melanoma, breast cancer, renal cancer and colorectal cancer. The incidence of brain metastases has been increasing but the occurrence of brain metastases is still associated with high morbidity and poor prognosis. The main treatment methods are stereotactic radiosurgery (SRS), microsurgical resection and whole brain irradiation (WBRT). In contrast to microsurgical resection, Gamma Knife radiosurgery (GKRS) is a non-invasive neurosurgical method, which allows treatment in multimorbid patients with contraindications for surgery in general anesthesia. Furthermore, stereotactic radiosurgery is the only local treatment method for multiple disseminated and thereby non-resectable brain metastases. In general, microsurgical resection is considered the treatment of choice for BM exceeding \>3 cm in diameter. However, since the establishment of the dose-staged technique, larger metastases can also be treated radiosurgically in selected patients. This novel method allows the application of high cumulative dose for the treatment of complex brain metastases. Aim. The aim of the study is to evaluate the clinical outcome in brain metastases patients with tumor volume between 8 and 20 ccm3. The clinical outcome will be compared between surgically and radiosurgically treated BM patients. Patients and methods. The investigators plan to conduct an explorative prospective study including about 50 radiosurgically and 50 surgically treated patients with brain metastases. If a patient fulfill study-relevant inclusion criteria at the time of BM diagnosis, the principle study investigator will offer both treatment options to the patient. Depending on patient's choice, he/she will be categorized either to surgical or to radiosurgical treatment group. For the outcome evaluation of the different treatment options, a comprehensive database will be established. The study participations will not interfere with any clincally indicated therapeutic decisions and the study participants will not be exposed to any additional risks since both treatments represent suitable therapy options.

Interventions

Depending on the patient's choice, the microsurgical resection of the brain metastases will be performed.

Depending on the patient's choice, the radiosurgical treatment of the brain metastases will be performed.

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Patients over 18 years and under 90 years * Patients with KPS ≥70 * Patients with NSCLC, melanoma, breast cancer or renal cancer as primary tumor * Maximum of three brain metastases on the diagnostic MRI * Tumor volume of 8-20 ccm3 on the diagnostic MRI * Lobular brain metastases * Patients without any contraindications for both treatment options * Written, signed informed consent for study particaption after study explanation

Exclusion criteria

* Patients under 18 years and over 90 years * Patients with KPS \<70 * Patients with other primary tumor * More than three brain metastases on the diagnostic MRI * Tumor volume \<8 or \>20 ccm3 on the diagnostic MRI * Patients with contraindications for both treatment options

Design outcomes

Primary

MeasureTime frameDescription
Overall survivalThrough completion of the study, an average of 1 yearTime from first treatment

Secondary

MeasureTime frameDescription
Local tumor progressionThrough completion of the study, an average of half a yearTime from first treatment until local tumor progression

Countries

Austria

Contacts

Primary ContactJosa Frischer, MD, PhD
josa.frischer@meduniwien.ac.at+43 1 40400 45510
Backup ContactAnna Cho, MD
anna.cho@meduniwien.ac.at+43 1 40400 45510

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026