Glucocorticoids, Immunotherapy and Radiosurgery for Brain Metastases

January 4, 2024 updated by: Josa M Frischer, MD, PhD, Medical University of Vienna

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Vienna, Austria, 1090
        • Department of Neurosurgery, Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients under 18 years
  • Patients over 90 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GK + IT
Gamma Knife and immunotherapy
GK + IT + GC
Gamma Knife, immunotherapy and glucocorticoids
Effect of glucocorticoids (which are often prescribed for cerebral edema) on clinical outcome
GK only
Gamma Knife without immunotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Through completion of the study, an average of 1 year
Time from first Gamma Knife Radiosurgical Treatment
Through completion of the study, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
New brain metastases
Time Frame: Through completion of the study, an average of half a year
Time until new brain metastases
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
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.
Through completion of the study, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Actual)

January 4, 2024

Study Completion (Actual)

January 4, 2024

Study Registration Dates

First Submitted

July 30, 2019

First Submitted That Met QC Criteria

July 31, 2019

First Posted (Actual)

August 1, 2019

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Brain Metastases

Clinical Trials on Glucocorticoids

3
Subscribe