About this trial
The study aims to assess the direct patient-reported perception (PROs) of individuals affected by IDH-mutant, grade 2 gliomas undergoing radiotherapy or pharmacological treatment with vorasidenib.
To evaluate quality of life, perception of treatment-related symptoms, and anxiety levels during therapy by comparing patients receiving radiotherapy with those receiving pharmacological treatment with vorasidenib. The control group will consist of patients with IDH-mutant, grade 2 gliomas who are under clinical and radiological follow-up only.
To assess the feasibility of using PROMs in routine clinical practice. To analyze patient-reported critical issues in order to qualitatively improve care pathways.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 18 years
Histological diagnosis of IDH mutant, grade 2 glioma
Consent to treatment
Consent to the administration of PROM questionnaires
Disqualifiers
Cognitive impairment or mental disability.
Dementia or severe cognitive disorders: participants who are unable to understand the questionnaire items are excluded, as the data may not be reliable.
Uncontrolled severe psychiatric disorders: conditions such as schizophrenia or untreated psychosis may compromise the patient's ability to provide consistent responses.
Language barriers.
Trial population
Adult population with LGG diagnosis receiving radiotherapy, vorasidenib or follow-up
Trial design
Other
Prospective
Treatments tested in this trial
Vorasidenib
Drugpatients receiving pharmacological treatment with vorasidenib, isocitrate dehydrogenase (IDH) inhibitor;
Radiotherapy
Procedure/SurgeryRadiotherapy: patients treated with radiotherapy for residual disease or recurrence;
active surveillance
Procedure/SurgeryFollow-up: patients undergoing active surveillance with periodic follow-up including MRI and clinical evaluation.
Treatment groups
Trial outcomes
Primary outcomes
Characterize and compare the experience of patients with IDH-mutant, grade 2 gliomas
To characterize and compare the experience of patients with IDH-mutant, grade 2 gliomas through the administration of PROs across different settings: radiotherapy, medical oncology, and in the absence of adjuvant treatments. Use of standardized questionnaires to evaluate quality of life, perception of treatment-related symptoms, and anxiety levels during therapy by comparing patients receiving radiotherapy with those receiving pharmacological treatment with vorasidenib. The control group will consist of patients with IDH-mutant, grade 2 gliomas who are under clinical and radiological follow-up only.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.