Dose-staged Gamma Knife Radiosurgery Versus Microsurgical Resection

NCT ID: NCT04857905

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2025-12-01

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.

Conditions

Brain Metastases

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: OTHER

Microsurgical resection

Intervention Type: PROCEDURE

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

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

Group Type: OTHER

Gamma Knife radiosurgery

Intervention Type: PROCEDURE

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

Interventions

Microsurgical resection

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

Intervention Type: PROCEDURE

Gamma Knife radiosurgery

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Josa M Frischer, MD, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Neurosurgery, Medical University of Vienna

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Josa Frischer, MD, PhD

Role: CONTACT

josa.frischer@meduniwien.ac.at

+43 1 40400 45510

Anna Cho, MD

Role: CONTACT

anna.cho@meduniwien.ac.at

+43 1 40400 45510

Facility Contacts

Josa M Frischer, MD, PhD

Role: primary

josa.frischer@meduniwien.ac.at

004314040045510

Anna Cho, MD

Role: backup

anna.cho@meduniwien.ac.at

004314040045510

Other Identifiers

EK 1623/2020

Identifier Type: -

Identifier Source: org_study_id