Study of Patient Experiences in IDH-mutant Grade 2 Glioma Treatment Comparing Vorasidenib Drug Therapy, Radiotherapy, and Active Surveillance
Led by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Updated on 2026-04-23
90
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the experiences of people diagnosed with IDH-mutant, grade 2 gliomas, a type of low-grade brain tumor. The study compares patient-reported quality of life, treatment-related symptoms, and anxiety levels among those receiving radiotherapy, those treated with the drug vorasidenib, and those under active surveillance. The study also aims to see how practical it is to use patient-reported outcome measures PROMs in routine care to help improve treatment pathways.
Participants are divided into three groups based on their treatment plan one group receives vorasidenib, an IDH inhibitor drug another undergoes radiotherapy for remaining or recurring tumor and the third group is monitored through active surveillance with regular MRI scans and clinical evaluations. Regardless of treatment, all participants complete questionnaires every six months for two years to provide their perspectives.
Throughout the study, participants provide information via questionnaires about their symptoms and quality of life. These patient-reported outcomes help researchers understand the impact of each treatment approach. The main outcome measured is the characterization and comparison of patients experiences over three years. This includes monitoring their wellbeing and any critical issues to support better care. The total participation time is at least two years with ongoing follow-up assessments.
CONDITIONS
Brief Title
Patient Voice in the Treatment of Low-grade Gliomas: Use of Patient-reported Outcomes, Vorasidenib and Radiotherapy Compared
Research Team
C
Cristiana Pedone, MD
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Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Lead Sponsor
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Age > 18 years
Histological diagnosis of IDH mutant, grade 2 glioma
Consent to treatment
Consent to the administration of patient-reported outcome questionnaires
You will not qualify if you...
Cognitive impairment or mental disability
Dementia or severe cognitive disorders preventing understanding of questionnaire items
Uncontrolled severe psychiatric disorders such as schizophrenia or untreated psychosis
Language barriers or inability to understand the language of the questionnaires
Literacy issues preventing reading or writing
Non-adherence or poor cooperation
Refusal to complete questionnaires
Conditions or medications that may affect questionnaire responses, such as sedatives or antipsychotics that impair cognitive abilities
Any condition that could influence questionnaire outcomes making data unreliable or inconsistent
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Varies according to treatment course
Participants receive pharmacological treatment with vorasidenib or radiotherapy according to clinical practice.
Visits as scheduled per clinical treatment plan
Surveillance
Duration - 2 years
Participants undergoing active surveillance are followed with periodic MRI and clinical evaluations.
Visits every 6 months for clinical evaluation and questionnaires
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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Published Research Related To This Trial
Comprehensive Genomic Analysis in NRG Oncology/RTOG 9802: A Phase III Trial of Radiation Versus Radiation Plus Procarbazine, Lomustine (CCNU), and Vincristine in High-Risk Low-Grade Glioma.
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Nathan I Cherny, Elisabeth G E de Vries, Urania Dafni...