Short Term Outcomes After PRoton and PhotoN RadiOtherapy for IDH Mutated Grade 2 and 3 Gliomas
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: proton therapy, photon therapy.
- Who it may be relevant to
- Registry conditions: Glioma, Radiotherapy; Complications. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Rationale: Proton beam therapy has recently become available for the treatment of patients with WHO grade 2 and 3 IDH mutated (IDHmt) glioma in the Netherlands. The dose distributions associated with proton therapy have substantially reduced the volume of the normal brain irradiated with low and intermediate radiotherapy doses. Whether this impacts rates of progressive disease or safety issues and how this compares with a similar population treated with photon therapy is currently unknown. Objective: To investigate short term outcomes after proton and photon radiotherapy for grade 2 and 3 IDHmt glioma.
Detailed description
Patients with grade 2 and 3 IDHmt glioma treated with proton therapy in Holland PTC, Maastro and UMC Groningen and referred Erasmus MC, Haaglanden MC, LUMC, Amsterdam UMC, Verbeeten Institute, Maastro, UMC Groningen, and Leuven University Hospital between 1st of January 2018 and the 30th of June 2022. The outcomes will be compared to those from patients with grade 2 and 3 IDHmt glioma treated with photon therapy in the same institutes and during the same period of time. The applied clinical target volume (CTV) margins and the chemotherapy are preferably similar for proton and photon therapy.
Retrospective data will be collected from the electronic records of each participating institute. For the primary outcome, data will be collected on interventions (radiotherapy, surgery, chemotherapy, medication) for either tumor progression or toxicity after radiotherapy. This will be used to calculate next intervention free survival as primary outcome.
For the secondary outcomes, data on survival, disease progression, pseudoprogression, and toxicity will be used to calculate overall survival, progression free survival, and pseudoprogression free survival, as well as toxicity incidence.
Interventions
- Radiation proton therapy
Radiotherapy delivered with protons - Radiation photon therapy
Radiotherapy delivered with photons
Primary outcome measures
- Next intervention-free survival [Time frame: 24 months]
Secondary outcome measures (4)
- Adverse Events [Time frame: 24 months]
- Overall survival [Time frame: 24 months]
- Progression-free survival [Time frame: 24 months]
- Pseudoprogression-free survival [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- Histopathologically confirmed WHO grade 2 or grade WHO 3 IDHmt glioma
- Treatment with radiotherapy delivered between 1 of January 2018 and completed before or on the 30th of June 2022
- Treatment with chemotherapy delivered after radiotherapy (PCV or Temozolomide)
- Age ≥ 18 years
Exclusion criteria
- Prior cranial radiotherapy
- Contra-indication for MRI imaging
- Chemotherapy delivered before radiotherapy
- Dose and fractionation other that standard dose (50.4 Gy in 28 fractions for Grade 2 and 59.5 Gy in 33 fractions for Grade 3)
- Combination photon and proton therapy
- Patient has previously opted-out of the use of their data for research
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- Erasmus MC — Rotterdam
Identifiers
NCT: NCT06180434 · MEC-2023-0727