BEVACIZUMAB for Glioblastoma multiforme

Inclusion criteria

• {"criterion_text":"-\tNot recurrent glioblastoma multiforme patients (either after opus or with no opus) before radiotherapy and temozolomide therapy.\n-\tRecurrent patients who have already undergone other therapeutic intervention (surgery, radiotherapy and temozolomide therapy) and due to the recurrence of the disease, based on clinical experience, it is justified to start bevacizumab therapy.\n-\tKnown relapse patients who are already receiving bevacizumab therapy."}

Exclusion criteria

• {"criterion_text":"-\tUnwillingness to sign the written Informed Consent Form.\n-\tHistory of psychiatric diseases and treatment.\n-\tHypersensitivity to the active substance or to any of the excipients.\n-\tHypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies.\n-\tParticipation in another clinical trial within 3 months prior to this study.\n-\tKnown drug or chronic alcohol abuse, drug addiction.\n-\tMalignant disease other than GBM.\n-\tLegal incapacity and/or other circumstances rendering the subject unable to understand the nature, scope and possible consequences of the study.\n-\tEvidence of an uncooperative attitude.\n-\tVulnerable subject."}

Primary endpoints

• {"endpoint_text":"-1.\tImmunological changes in patients during the course of the disease before and under bevacizumab treatment, which might predict the course of the disease.\n-2.\tLocal relapse free survival\n-3.\tProgression free survival\n-4.\tOverall survival.","definition_or_measurement_approach":"Immunological changes: measured in patients during the course of disease before and under bevacizumab treatment (no further measurement details provided). Local relapse free survival, Progression free survival and Overall survival: listed as survival endpoints but no specific definitions, timepoints or assessment methods are provided in the record."}

Secondary endpoints

• {"endpoint_text":"-Investigation of plasma-derived extracellular vesicles (EV), their micro-RNA and protein content, and free DNA-RNA fragments. We do not perform genome sequencing.","definition_or_measurement_approach":"Analysis of plasma-derived extracellular vesicles (EV) including micro-RNA and protein content, and free DNA/RNA fragments. The record explicitly states genome sequencing is not performed. No further assay/method details provided."}

Hungary

Earliest CTIS Part Ii Submission Date

22-02-2024

Latest Decision Or Authorization Date

28-06-2024

Processing Time Days

127

Number Of Sites

2

Number Of Participants

175

Primary sponsor

Full Name

Orszagos Onkologiai Intezet

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Hungary

Third parties

• {"country":"","full_name":"National Institute of Oncology","duties_or_roles":"Source of monetary support","organisation_type":""}