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

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.

Study Overview

• Status: Recruiting
• Conditions: Brain Metastases
• Intervention / Treatment: Procedure: Microsurgical resection; Procedure: Gamma Knife radiosurgery

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Josa Frischer, MD, PhD; Phone Number: +43 1 40400 45510; Email: josa.frischer@meduniwien.ac.at
• Study Contact Backup: Name: Anna Cho, MD; Phone Number: +43 1 40400 45510; Email: anna.cho@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Department of Neurosurgery, Medical University of Vienna
    • Contact: Josa M Frischer, MD, PhD; Phone Number: 004314040045510; Email: josa.frischer@meduniwien.ac.at
    • Contact: Anna Cho, MD; Phone Number: 004314040045510; Email: anna.cho@meduniwien.ac.at
    • Principal Investigator: Christian Dorfer, MD
    • Sub-Investigator: Karl Rössler, MD
    • Sub-Investigator: Barbara Kiesel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Microsurgical Resection of larger Brain Metastasis; 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 counseling -> Patients who after counseling decide for microsurgical resection of their brain metastasis	Procedure: Microsurgical resection; Depending on the patient's choice, the microsurgical resection of the brain metastases will be performed.
Other: Radiosurgery of larger Brain Metastasis; 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 counseling -> Patients who after counseling decide for dose-staged radiosurgical treatment of their brain metastasis	Procedure: Gamma Knife radiosurgery; Depending on the patient's choice, the radiosurgical treatment of the brain metastases will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Time from first treatment	Through completion of the study, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local tumor progression	Time from first treatment until local tumor progression	Through completion of the study, an average of half a year

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: April 15, 2021
• First Submitted That Met QC Criteria: April 20, 2021
• First Posted (Actual): April 23, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Brain metastases; Gamma Knife Radiosurgery; Microsurgical resection
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Neoplastic Processes; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasm Metastasis; Brain Neoplasms
• Other Study ID Numbers: EK 1623/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No