Dose-staged Gamma Knife Radiosurgery Versus Microsurgical Resection

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 90 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04857905
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Medical University of Vienna
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Austria
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Metastases

Arms & Interventions

Arms

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

Interventions

Procedure: - Microsurgical resection

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

Procedure: - Gamma Knife radiosurgery

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

Contact a Trial Team

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