Dose-staged Gamma Knife Radiosurgery Versus Microsurgical Resection

NCT04857905 | Unknown

• 1 other identifier: EK 1623/2020
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Gamma Knife Radiosurgery; Brain metastases; Microsurgical resection

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Time from first treatment

  Through completion of the study, an average of 1 year

Secondary Outcomes (1)

• Local tumor progression

  Through completion of the study, an average of half a year

Study Arms (2)

Microsurgical Resection of larger Brain Metastasis

OTHER

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

Radiosurgery of larger Brain Metastasis

OTHER

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

Interventions

Microsurgical resection PROCEDURE

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

Microsurgical Resection of larger Brain Metastasis

Gamma Knife radiosurgery PROCEDURE

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

Radiosurgery of larger Brain Metastasis

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Neurosurgery, Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Josa Frischer, MD, PhD

CONTACT

+43 1 40400 45510; josa.frischer@meduniwien.ac.at

Anna Cho, MD

CONTACT

+43 1 40400 45510; anna.cho@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 15, 2021
• First Posted: April 23, 2021
• Study Start: July 1, 2020
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)