Brain MetastasesNCT04042220
Glucocorticoids, Immunotherapy and Radiosurgery for Brain Metastases
An observational study of Brain Metastases, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Background. Brain metastases 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?
- Glucocorticoids
- How many people
- 200 participants
- Where
- 1 siteAustria
- Study dates
- 1 Nov 2019to 4 Jan 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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
Study population: Patients will be included in our study, if they were diagnosed with one of two most common primary cancers (lung cancer or melanoma) and were treated with at least one Gamma Knife radiosurgical treatment for at least one brain metastasis.
Who may be able to join
- Patients, who were treated with Gamma Knife Radiosurgery for at least one or more brain metastases and diagnosed with one of two most common primary cancers (lung cancer or melanoma)
- Patients over 18 years and under 90 years
- Written, signed informed consent for study particaption after study explanation
Who cannot join
- Patients under 18 years
- Patients over 90 years
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Neurosurgery, Medical University of Vienna
Vienna, 1090
About this study
Official title: Effect of Glucocorticoids on the Outcome of Gamma Knife Radiosurgically Treated Patients With Brain Metastases During Immunotherapy - An Explorative Study
Background. Brain metastases 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). The stereotactic Gamma Knife Radiosurgery (GKRS) is a non-invasive method, applying high dose radiation into an exact defined volume within the cranium, and thereby associated with significantly decreased neurotoxicity. It is the only treatment method for multiple disseminated and thereby non-resectable brain metastases. A novel treatment method of brain metastases is the combination of GKRS and systematic immunotherapy (IT), targeted therapy (TT) or chemotherapy, which showed significant improvements in survival. Furthermore, patients with brain metastases often develop cerebral edema, which is commonly treated with glucocorticoids to relieve the symptoms and decrease the fluid accumulation, but the long-term use was shown to be unfavorable due to various side effects. One of the potentially concerning side effect of glucocorticoids is the immunosuppressive properties. This raises the question of whether glucocorticoids might influence the effect of immunotherapy.
Aim. The aim of the study is to evaluate if the use of glucocorticoids before, during and after treatment with gamma knife radiosurgery and immunotherapy effect the overall survival in patients with brain metastases, in contrast to patients undergoing gamma knife radiosurgery and immunotherapy alone. In addition, the effect of glucocorticoids on progression-free survival and clinical outcome will be evaluated. For the evaluation of the modern oncological treatment, patients with gamma knife radiosurgery, receiving immunotherapy, will be compared to patients not receiving immunotherapy.
Patients and methods. The investigators plan to conduct a observational prospective preliminary study including about 200 radiosurgically treated patients with brain metastases. Patients will be included to our study, if they were diagnosed with one of two most common primary cancers (lung cancer or melanoma) and were treated with at least one Gamma Knife radiosurgical treatment for at least one brain metastasis. 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.
- Conditions
- Brain Metastases
- Being tested
- Glucocorticoids
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucocorticoidsDrug
Effect of glucocorticoids (which are often prescribed for cerebral edema) on clinical outcome
| Study group | Role | What they receive |
|---|---|---|
| GK + IT | Gamma Knife and immunotherapy | |
| GK + IT + GC | Gamma Knife, immunotherapy and glucocorticoids Receives: Drug: Glucocorticoids | |
| GK only | Gamma Knife without immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Time from first Gamma Knife Radiosurgical Treatment
Measured: Through completion of the study, an average of 1 year
Secondary outcomes (2)
New brain metastases
Time until new brain metastases
Measured: Through completion of the study, an average of half a year
Clinical outcome according to Karnofsky Performance Status Scale (KPS)
Clinical condition at last follow up according to KPS. The KPS uses steps of 10%. Patients with 100% are not affected by their disease in everday activities, whereas 0% equals death.
Measured: Through completion of the study, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start1 Nov 2019
- Primary completion4 Jan 2024
- Study completion4 Jan 2024
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
- Target duration
- 6 Months
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
- NCT04042220
- Sponsor's protocol ID
- 1648/2019
- Status last verified
- Jan 2024
- First submitted
- 30 Jul 2019
- 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
- Effect of Glucocorticoids on the Outcome of Gamma Knife Radiosurgically Treated Patients With Brain Metastases During Immunotherapy - An Explorative Study
- ClinicalTrials.gov ID
- NCT04042220
- Acronym / sponsor ID
- 1648/2019
- Conditions
- Brain Metastases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 4 Jan 2024 (actual)
- Study completion
- 4 Jan 2024 (actual)
- First posted
- 1 Aug 2019 (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 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). The stereotactic Gamma Knife Radiosurgery (GKRS) is a non-invasive method, applying high dose radiation into an exact defined volume within the cranium, and thereby associated with significantly decreased neurotoxicity. It is the only treatment method for multiple disseminated and thereby non-resectable brain metastases. A novel treatment method of brain metastases is the combination of GKRS and systematic immunotherapy (IT), targeted therapy (TT) or chemotherapy, which showed significant improvements in survival. Furthermore, patients with brain metastases often develop cerebral edema, which is commonly treated with glucocorticoids to relieve the symptoms and decrease the fluid accumulation, but the long-term use was shown to be unfavorable due to various side effects. One of the potentially concerning side effect of glucocorticoids is the immunosuppressive properties. This raises the question of whether glucocorticoids might influence the effect of immunotherapy.
Aim. The aim of the study is to evaluate if the use of glucocorticoids before, during and after treatment with gamma knife radiosurgery and immunotherapy effect the overall survival in patients with brain metastases, in contrast to patients undergoing gamma knife radiosurgery and immunotherapy alone. In addition, the effect of glucocorticoids on progression-free survival and clinical outcome will be evaluated. For the evaluation of the modern oncological treatment, patients with gamma knife radiosurgery, receiving immunotherapy, will be compared to patients not receiving immunotherapy.
Patients and methods. The investigators plan to conduct a observational prospective preliminary study including about 200 radiosurgically treated patients with brain metastases. Patients will be included to our study, if they were diagnosed with one of two most common primary cancers (lung cancer or melanoma) and were treated with at least one Gamma Knife radiosurgical treatment for at least one brain metastasis. 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GK + IT | – | –Gamma Knife and immunotherapy |
| GK + IT + GC | – | Drug: GlucocorticoidsGamma Knife, immunotherapy and glucocorticoids |
| GK only | – | –Gamma Knife without immunotherapy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be included in our study, if they were diagnosed with one of two most common primary cancers (lung cancer or melanoma) and were treated with at least one Gamma Knife radiosurgical treatment for at least one brain metastasis.
Key inclusion criteria (3 listed)
- Patients, who were treated with Gamma Knife Radiosurgery for at least one or more brain metastases and diagnosed with one of two most common primary cancers (lung cancer or melanoma)
- Patients over 18 years and under 90 years
- Written, signed informed consent for study particaption after study explanation
Key exclusion criteria (2 listed)
- Patients under 18 years
- Patients over 90 years
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 |
|---|---|---|
| GlucocorticoidsEffect of glucocorticoids (which are often prescribed for cerebral edema) on clinical outcome | Drug | GK + IT + GC |
Primary outcome
Overall survival
Time frame: Through completion of the study, an average of 1 year
Time from first Gamma Knife Radiosurgical Treatment
2 secondary outcomes
New brain metastases
Time frame: Through completion of the study, an average of half a year
Clinical outcome according to Karnofsky Performance Status Scale (KPS)
Time frame: Through completion of the study, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 3 inclusion and 2 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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.