Glucocorticoids, Immunotherapy and Radiosurgery for Brain Metastases
Condition: Brain Metastases
MeSH terms: Neoplasm Metastasis; Brain Neoplasms
Study type: Observational [Patient Registry]

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. 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.
    


Intervention name(s): Glucocorticoids
Intervention type(s): Drug
Intervention description(s): Effect of glucocorticoids (which are often prescribed for cerebral edema) on clinical outcome
Intervention MeSH terms: Glucocorticoids
Observational model: Cohort
Time perspective: Prospective
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.