JOURNAL ONKOLOGIE – STUDIE

Dose-staged Gamma Knife Radiosurgery Versus Microsurgical Resection

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT04857905

Studienbeginn:
Juli 2020

Letztes Update:
05.01.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Neoplasm Metastasis, Brain Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Medical University of Vienna

Collaborator:
-

Kontakt

Josa Frischer, MD, PhD
Kontakt:
Phone: +43 1 40400 45510
E-Mail: josa.frischer@meduniwien.ac.at» Kontaktdaten anzeigen

Anna Cho, MD
Kontakt:
Phone: +43 1 40400 45510
E-Mail: anna.cho@meduniwien.ac.at» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Department of Neurosurgery, Medical University of Vienna
1090 Vienna
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Josa M Frischer, MD, PhD
Phone: 004314040045510
E-Mail: josa.frischer@meduniwien.ac.at

Anna Cho, MD
Phone: 004314040045510
E-Mail: anna.cho@meduniwien.ac.at» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Overall survival (Time Frame - Through completion of the study, an average of 1 year):
Time from first treatment

Secondary outcome:

1. Local tumor progression (Time Frame - Through completion of the study, an average of half a year):
Time from first treatment until local tumor progression

Studien-Arme

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
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

Geprüfte Regime

Microsurgical resection:
Depending on the patient's choice, the microsurgical resection of the brain metastases will be performed.
Gamma Knife radiosurgery:
Depending on the patient's choice, the radiosurgical treatment of the brain metastases will be performed.

Quelle: ClinicalTrials.gov

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