Short Term Outcomes After PRoton and PhotoN RadiOtherapy for IDH Mutated Grade 2 and 3 Gliomas
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorErasmus Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- proton therapy
- photon therapy
Treatment groups
320 Participants
are divided into 2 treatment groupsSponsors and collaborators
Erasmus Medical Center
Lead sponsor
Medical Center Haaglanden
Collaborator
Leiden University Medical Center
Collaborator
HollandPTC
Collaborator
Institute Verbeeten
Collaborator
Universitaire Ziekenhuizen KU Leuven
Collaborator
University Medical Center Groningen
Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborator
Maastro Clinic, The Netherlands
Collaborator
Source ClinicalTrials.gov