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

NCT07547163 | Recruiting

• 1 other identifier: LGG PRO's
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Patient Reported Outcomes; glioma; Low Grade Gliomas; grade 2 glioma; IDH mutant

Outcome Measures

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.

  3 years

Study Arms (3)

Group 1

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

Drug: Vorasidenib

Group 2

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

Procedure: Radiotherapy

Group 3

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

Procedure: active surveillance

Interventions

Vorasidenib DRUG

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

Group 1

Radiotherapy PROCEDURE

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

Group 2

active surveillance PROCEDURE

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

Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult population with LGG diagnosis receiving radiotherapy, vorasidenib or follow-up

You may qualify if:

• Age \> 18 years
• Histological diagnosis of IDH mutant, grade 2 glioma
• Consent to treatment
• Consent to the administration of PROM questionnaires

You may not qualify if:

• 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.
• Inability to understand the language of the questionnaire: participants who do not speak or understand the language in which the questionnaire is written are excluded if validated translations are not available.
• Literacy issues: participants who are unable to read or write are excluded.
• Non-adherence or poor cooperation.
• Conditions that may influence questionnaire outcomes.
• Use of medications that impair cognitive abilities: the use of sedatives or antipsychotics may affect the ability to provide coherent responses, compromising the validity of PROs.

Sponsors & Collaborators

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

Study Sites (1)

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Italy

RECRUITING

Related Publications (10)

• Silvani A. New perspectives: Glioma in adult patients. Tumori. 2023 Aug;109(4):350-355. doi: 10.1177/03008916231159716. Epub 2023 Mar 24.

  PMID: 36964665 BACKGROUND

• Balitsky AK, Rayner D, Britto J, Lionel AC, Ginsberg L, Cho W, Wilfred AM, Sardar H, Cantor N, Mian H, Levine MN, Guyatt GH. Patient-Reported Outcome Measures in Cancer Care: An Updated Systematic Review and Meta-Analysis. JAMA Netw Open. 2024 Aug 1;7(8):e2424793. doi: 10.1001/jamanetworkopen.2024.24793.

  PMID: 39136947 BACKGROUND

• Mellinghoff IK, van den Bent MJ, Blumenthal DT, Touat M, Peters KB, Clarke J, Mendez J, Yust-Katz S, Welsh L, Mason WP, Ducray F, Umemura Y, Nabors B, Holdhoff M, Hottinger AF, Arakawa Y, Sepulveda JM, Wick W, Soffietti R, Perry JR, Giglio P, de la Fuente M, Maher EA, Schoenfeld S, Zhao D, Pandya SS, Steelman L, Hassan I, Wen PY, Cloughesy TF; INDIGO Trial Investigators. Vorasidenib in IDH1- or IDH2-Mutant Low-Grade Glioma. N Engl J Med. 2023 Aug 17;389(7):589-601. doi: 10.1056/NEJMoa2304194. Epub 2023 Jun 4.

  PMID: 37272516 BACKGROUND

• Bell EH, Zhang P, Shaw EG, Buckner JC, Barger GR, Bullard DE, Mehta MP, Gilbert MR, Brown PD, Stelzer KJ, McElroy JP, Fleming JL, Timmers CD, Becker AP, Salavaggione AL, Liu Z, Aldape K, Brachman DG, Gertler SZ, Murtha AD, Schultz CJ, Johnson D, Laack NN, Hunter GK, Crocker IR, Won M, Chakravarti A. 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. J Clin Oncol. 2020 Oct 10;38(29):3407-3417. doi: 10.1200/JCO.19.02983. Epub 2020 Jul 24.

  PMID: 32706640 BACKGROUND

• van den Bent MJ, Afra D, de Witte O, Ben Hassel M, Schraub S, Hoang-Xuan K, Malmstrom PO, Collette L, Pierart M, Mirimanoff R, Karim AB; EORTC Radiotherapy and Brain Tumor Groups and the UK Medical Research Council. Long-term efficacy of early versus delayed radiotherapy for low-grade astrocytoma and oligodendroglioma in adults: the EORTC 22845 randomised trial. Lancet. 2005 Sep 17-23;366(9490):985-90. doi: 10.1016/S0140-6736(05)67070-5.

  PMID: 16168780 BACKGROUND

• Louis DN, Perry A, Wesseling P, Brat DJ, Cree IA, Figarella-Branger D, Hawkins C, Ng HK, Pfister SM, Reifenberger G, Soffietti R, von Deimling A, Ellison DW. The 2021 WHO Classification of Tumors of the Central Nervous System: a summary. Neuro Oncol. 2021 Aug 2;23(8):1231-1251. doi: 10.1093/neuonc/noab106.

  PMID: 34185076 BACKGROUND

• Di Maio M, Basch E, Denis F, Fallowfield LJ, Ganz PA, Howell D, Kowalski C, Perrone F, Stover AM, Sundaresan P, Warrington L, Zhang L, Apostolidis K, Freeman-Daily J, Ripamonti CI, Santini D; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. The role of patient-reported outcome measures in the continuum of cancer clinical care: ESMO Clinical Practice Guideline. Ann Oncol. 2022 Sep;33(9):878-892. doi: 10.1016/j.annonc.2022.04.007. Epub 2022 Apr 21. No abstract available.

  PMID: 35462007 BACKGROUND

• Cherny NI, de Vries EGE, Dafni U, Garrett-Mayer E, McKernin SE, Piccart M, Latino NJ, Douillard JY, Schnipper LE, Somerfield MR, Bogaerts J, Karlis D, Zygoura P, Vervita K, Pentheroudakis G, Tabernero J, Zielinski C, Wollins DS, Schilsky RL. Comparative Assessment of Clinical Benefit Using the ESMO-Magnitude of Clinical Benefit Scale Version 1.1 and the ASCO Value Framework Net Health Benefit Score. J Clin Oncol. 2019 Feb 1;37(4):336-349. doi: 10.1200/JCO.18.00729. Epub 2018 Dec 17.

  PMID: 30707056 BACKGROUND

• Calvert M, Kyte D, Mercieca-Bebber R, Slade A, Chan AW, King MT; the SPIRIT-PRO Group; Hunn A, Bottomley A, Regnault A, Chan AW, Ells C, O'Connor D, Revicki D, Patrick D, Altman D, Basch E, Velikova G, Price G, Draper H, Blazeby J, Scott J, Coast J, Norquist J, Brown J, Haywood K, Johnson LL, Campbell L, Frank L, von Hildebrand M, Brundage M, Palmer M, Kluetz P, Stephens R, Golub RM, Mitchell S, Groves T. Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension. JAMA. 2018 Feb 6;319(5):483-494. doi: 10.1001/jama.2017.21903.

  PMID: 29411037 BACKGROUND

• Nekhlyudov L, Mollica MA, Jacobsen PB, Mayer DK, Shulman LN, Geiger AM. Developing a Quality of Cancer Survivorship Care Framework: Implications for Clinical Care, Research, and Policy. J Natl Cancer Inst. 2019 Nov 1;111(11):1120-1130. doi: 10.1093/jnci/djz089.

  PMID: 31095326 BACKGROUND

MeSH Terms

Conditions

Glioma

Interventions

vorasidenib; Radiotherapy; Watchful Waiting

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Therapeutics; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Sara Morlino, MD

  Fondazione IRCCS Istituto Neurologico Carlo Besta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristiana Pedone, MD

CONTACT

+ 02 2394; cristiana.pedone@istituto-besta.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 23, 2026
• Study Start: April 23, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-03

Locations

IT (1)