Short Term Outcomes After PRoton And photoN radiOtherapy for IDH Mutated Grade 2 and 3 Gliomas

Glioma Clinical Trial

— SOPRANO  

Official title:

Short Term Outcomes After PRoton And photoN radiOtherapy for IDH Mutated Grade 2 and 3 Gliomas

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06180434
• Other study ID #: MEC-2023-0727
• Status: Not yet recruiting
• Start date: February 1, 2024
• Est. completion date: November 1, 2025

Study information

• Verified date: December 2023
• Source: Erasmus Medical Center
• Contact: Steven HJ Nagtegaal, MD PhD
• Phone: +31(0)107042249
• Email: s.nagtegaal[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 320
• Est. completion date: November 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioma
• Radiotherapy; Complications

Locations

Country	Name	City	State
n/a

Sponsors (9)

Lead Sponsor	Collaborator
Erasmus Medical Center	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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 months
Secondary	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.	24 months
Secondary	Overall survival	Measured from the last day of radiotherapy to death from any cause	24 months
Secondary	Progression-free survival	Time from the last day of radiotherapy until progressive disease	24 months
Secondary	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	24 months