Patient Voice in the Treatment of Low-grade Gliomas: Use of Patient-reported Outcomes, Vorasidenib and Radiotherapy Compared

Sponsor
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Study ID
NCT07547163
Status
Recruiting
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Conditions

  • Glioma
  • Glioma of Brain
  • IDH Mutation
  • Low Grade Glioma of Brain
  • Low Grade Gliomas

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vorasidenib — DRUG
    patients receiving pharmacological treatment with vorasidenib, isocitrate dehydrogenase (IDH) inhibitor;
  • Radiotherapy — PROCEDURE
    Radiotherapy: patients treated with radiotherapy for residual disease or recurrence;
  • active surveillance — PROCEDURE
    Follow-up: patients undergoing active surveillance with periodic follow-up including MRI and clinical evaluation.

Study Details

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.

Key Dates

Start date
Apr 23, 2025
Status verified
Mar 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
90 participants (estimated)

Arms

  • Arm: Group 1
    vorasidenib: patients receiving pharmacological treatment with vorasidenib, isocitrate dehydrogenase (IDH) inhibitor;
  • Arm: Group 2
    Radiotherapy: patients treated with radiotherapy for residual disease or recurrence;
  • Arm: Group 3
    Follow-up: patients undergoing active surveillance with periodic follow-up including MRI and clinical evaluation.

Primary Outcome Measure

Characterize and compare the experience of patients with IDH-mutant, grade 2 gliomas [ Time Frame: 3 years ]

Central Contacts

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