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

NCT07547163 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2026-04-23

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Vorasidenib

patients receiving pharmacological treatment with vorasidenib, isocitrate dehydrogenase (IDH) inhibitor;

PROCEDURE

Radiotherapy

Radiotherapy: patients treated with radiotherapy for residual disease or recurrence;

PROCEDURE

active surveillance

Follow-up: patients undergoing active surveillance with periodic follow-up including MRI and clinical evaluation.

Sponsors & Collaborators

  • Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

    lead OTHER

Principal Investigators

  • Sara Morlino, MD · Fondazione IRCCS Istituto Neurologico Carlo Besta

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-23
Primary Completion
2027-10-31
Completion
2027-10-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07547163 on ClinicalTrials.gov