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NCT Number: NCT06180434

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

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.

Recruiting

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Erasmus MC

Rotterdam, Netherlands

Location status: Recruiting

Location contact

Steven Nagtegaal, MD PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

proton therapy

Radiation

Radiotherapy delivered with protons

photon therapy

Radiation

Radiotherapy delivered with photons

Primary outcomes

  1. Next intervention-free survival

    Time frame: 24 months

    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.

Secondary outcomes

  1. Adverse Events

    Time frame: 24 months

    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.

  2. Overall survival

    Time frame: 24 months

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

  3. Progression-free survival

    Time frame: 24 months

    Time from the last day of radiotherapy until progressive disease

  4. Pseudoprogression-free survival

    Time frame: 24 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Alejandra Mendez Romero, MD PhD

CONTACT

[email protected]

+31(0)107035829

Steven HJ Nagtegaal, MD PhD

CONTACT

[email protected]

+31(0)107042249

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • HollandPTC
  • Institute Verbeeten
  • Leiden University Medical Center
  • Maastro Clinic, The Netherlands
  • Medical Center Haaglanden
  • Universitaire Ziekenhuizen KU Leuven
  • University Medical Center Groningen

Registry information

Acronym: SOPRANO

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 22, 2023
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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