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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Vorasidenib

    Drug

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

  • Radiotherapy

    Procedure/Surgery

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

  • active surveillance

    Procedure/Surgery

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

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Group 11 intervention
Group B: Group 21 intervention
Group C: Group 31 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
3 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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