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Short Term Outcomes After PRoton and PhotoN RadiOtherapy for IDH Mutated Grade 2 and 3 Gliomas

ConditionsGliomaRadiotherapy; Complications
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

This trial does not accept healthy volunteers

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 population

Adult patients treated with proton radiation therapy for grade 2 and 3 IDHmt glioma referred to HollandPTC, Maastro and UMC Groningen from the 1st of January 2018 of and the 30th of June 2022. The photon group will consist of patients treated with photon radiation therapy within the same period in Erasmus MC, Haaglanden MC, LUMC, Amsterdam UMC, Verbeeten Institute, Maastro, UMC Groningen, and Leuven University Hospital. The reason for choosing this time interval is that the Dutch guideline for the treatment of glioma was updated regarding margins in December 2017. From January 2018 patients with grade 2 glioma were treated with a 5mm CTV margin to compensate for microscopic invasion. Patients with grade 3 IDHmt tumors were treated with 10mm CTV margins.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • proton therapy

    Radiation

    Radiotherapy delivered with protons

  • photon therapy

    Radiation

    Radiotherapy delivered with photons

Treatment groups

320 Participants
are divided into 2 treatment groups
Group A: Proton group1 intervention
Group B: Photon group1 intervention

Trial outcomes

Primary outcomes

1

Next intervention-free survival

Time from the last day of radiotherapy until the start of a new next intervention. Next intervention is defined as either neurosurgical re-operation, re-irradiation, start of new chemotherapy (other than the standard adjuvant chemotherapy), start of VGEF inhibitors such as bevacizumab, or new start of dexamethasone for either tumor progression or radiotherapy effects.

Time frame
24 months

Secondary outcomes

1

Adverse Events

Assessed and scored based on the Common Terminology Criteria for Adverse Events (CTCAEv5.0). Only grade 3, 4 and 5 adverse events will be recorded.

Time frame
24 months
2

Overall survival

Measured from the last day of radiotherapy to death from any cause

Time frame
24 months
3

Progression-free survival

Time from the last day of radiotherapy until progressive disease

Time frame
24 months
4

Pseudoprogression-free survival

time from the last day of radiotherapy and the development of any transient contrast-enhancing lesion between the end of radiotherapy and disease progression, or any new contrast-enhancing lesion that remained stable over a period of 12 months

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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
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