Brain MetastasesNCT04857905
Dose-staged Gamma Knife Radiosurgery Versus Microsurgical Resection
A study testing Microsurgical resection and Gamma Knife radiosurgery in people with Brain Metastases, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Brain Metastases
- What is being tested?
- Microsurgical resection and Gamma Knife radiosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jul 2020to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Department of Neurosurgery, Medical University of Vienna
Vienna, 1090
Josa M Frischer, MD, PhD, 004314040045510, josa.frischer@meduniwien.ac.at
Anna Cho, MD, 004314040045510, anna.cho@meduniwien.ac.at
About this study
Official title: 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.
- Conditions
- Brain Metastases
- Being tested
- Microsurgical resection, Gamma Knife radiosurgery
- Keywords
- Gamma Knife Radiosurgery, Brain metastases, Microsurgical resection
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microsurgical resectionProcedure or surgery
Depending on the patient's choice, the microsurgical resection of the brain metastases will be performed.
Gamma Knife radiosurgeryProcedure or surgery
Depending on the patient's choice, the radiosurgical treatment of the brain metastases will be performed.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Gamma Knife radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Time from first treatment
Measured: Through completion of the study, an average of 1 year
Secondary outcomes (1)
Local tumor progression
Time from first treatment until local tumor progression
Measured: Through completion of the study, an average of half a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start1 Jul 2020
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josa M Frischer, MD, PhD, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857905
- Sponsor's protocol ID
- EK 1623/2020
- Status last verified
- Jan 2024
- First submitted
- 15 Apr 2021
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-staged Gamma Knife Radiosurgery Versus Microsurgical Resection - Evaluation of Neurosurgical Treatment Methods for Patients With Larger Brain Metastases - an Explorative Prospective Study
- ClinicalTrials.gov ID
- NCT04857905
- Acronym / sponsor ID
- EK 1623/2020
- Conditions
- Brain Metastases
- Keywords
- Gamma Knife Radiosurgery, Brain metastases, Microsurgical resection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 23 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microsurgical Resection of larger Brain Metastasis | Other | Procedure: Microsurgical resectionPatients 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 |
| Radiosurgery of larger Brain Metastasis | Other | Procedure: Gamma Knife radiosurgeryPatients 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microsurgical resectionDepending on the patient's choice, the microsurgical resection of the brain metastases will be performed. | Procedure or surgery | Microsurgical Resection of larger Brain Metastasis |
| Gamma Knife radiosurgeryDepending on the patient's choice, the radiosurgical treatment of the brain metastases will be performed. | Procedure or surgery | Radiosurgery of larger Brain Metastasis |
Primary outcome
Overall survival
Time frame: Through completion of the study, an average of 1 year
Time from first treatment
1 secondary outcome
Local tumor progression
Time frame: Through completion of the study, an average of half a year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microsurgical resection and Gamma Knife radiosurgery in people with Brain Metastases, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Josa Frischer, MD, PhD (+43 1 40400 45510, josa.frischer@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Through completion of the study, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.