GliomaLGG PRO'sNCT07547163
Patient Voice in the Treatment of Low-grade Gliomas: Use of Patient-reported Outcomes, Vorasidenib and Radiotherapy Compared
An observational study of Glioma and Glioma of Brain, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Glioma of Brain, Low Grade Glioma of Brain
- What is being tested?
- Vorasidenib, Radiotherapy and active surveillance
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 23 Apr 2025to Oct 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult population with LGG diagnosis receiving radiotherapy, vorasidenib or follow-up
Who may be able to join
- Age > 18 years
- Histological diagnosis of IDH mutant, grade 2 glioma
- Consent to treatment
- Consent to the administration of PROM questionnaires
Who cannot join
- 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.
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- Non-adherence or poor cooperation.
- Refusal to complete the questionnaires: even if the patient agrees to participate in the study, the specific refusal to complete the questionnaires leads to exclusion.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan
Cristiana Pedone, MD, + 39 02.2394, cristiana.pedone@istituto-besta.it
Sara Morlino, MD, 0039.02.2394, sara.morlino@istituto-besta.it
About this study
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.
Read the detailed description
Patients with IDH-mutant grade 2 gliomas whose therapeutic pathway is defined according to clinical practice.
They are divided into three groups:
- patients receiving pharmacological treatment with vorasidenib, isocitrate dehydrogenase (IDH) inhibitor;
- patients treated with radiotherapy for residual disease or recurrence;
- patients undergoing active surveillance with periodic follow-up including MRI and clinical evaluation.
These patients are asked to complete the questionnaires every 6 months for two years, regardless of the ongoing clinical pathway.
- Being tested
- Vorasidenib, Radiotherapy, active surveillance
- Keywords
- Patient Reported Outcomes, glioma, Low Grade Gliomas, grade 2 glioma, IDH mutant
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VorasidenibDrug
patients receiving pharmacological treatment with vorasidenib, isocitrate dehydrogenase (IDH) inhibitor;
RadiotherapyProcedure or surgery
Radiotherapy: patients treated with radiotherapy for residual disease or recurrence;
active surveillanceProcedure or surgery
Follow-up: patients undergoing active surveillance with periodic follow-up including MRI and clinical evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | vorasidenib: patients receiving pharmacological treatment with vorasidenib, isocitrate dehydrogenase (IDH) inhibitor; Receives: Drug: Vorasidenib | |
| Group 2 | Radiotherapy: patients treated with radiotherapy for residual disease or recurrence; Receives: Procedure: Radiotherapy | |
| Group 3 | Follow-up: patients undergoing active surveillance with periodic follow-up including MRI and clinical evaluation. Receives: Procedure: active surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start23 Apr 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Morlino, MD, Principal investigator, Fondazione IRCCS Istituto Neurologico Carlo Besta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07547163
- Sponsor's protocol ID
- LGG PRO's
- Acronym
- LGG PRO's
- Status last verified
- Mar 2026
- First submitted
- 17 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Silvani A. New perspectives: Glioma in adult patients. Tumori. 2023 Aug;109(4):350-355. doi: 10.1177/03008916231159716. Epub 2023 Mar 24.
PubMed 36964665Balitsky 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.
PubMed 39136947Mellinghoff 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.
PubMed 37272516Bell 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.
PubMed 32706640van 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.
PubMed 16168780Louis 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.
PubMed 34185076Di 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.
PubMed 35462007Cherny 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.
PubMed 30707056Calvert 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.
PubMed 29411037Nekhlyudov 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.
PubMed 31095326