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

NCT06180434 | Recruiting DMC

• 1 other identifier: MEC-2023-0727
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glioma; Radiotherapy; Complications

Keywords

Neuro-oncology; Proton therapy; Photon therapy

Outcome Measures

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.

  24 months

Secondary Outcomes (4)

• Adverse Events

  24 months

• Overall survival

  24 months

• Progression-free survival

  24 months

• Pseudoprogression-free survival

  24 months

Study Arms (2)

Proton group

Patients with grade 2 and 3 IDHmt glioma treated with proton therapy in Holland PTC, Maastro Clinic and UMC Groningen.

Radiation: proton therapy

Photon group

Patients with grade 2 and 3 IDHmt glioma treated with photon therapy in Erasmus MC, Haaglanden MC, LUMC, Amsterdam UMC locatie VUmc Site, Verbeeten Institute, Maastro Clinic, UMC Groningen, and Leuven University Hospital.

Radiation: photon therapy

Interventions

proton therapy RADIATION

Radiotherapy delivered with protons

Proton group

photon therapy RADIATION

Radiotherapy delivered with photons

Photon group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead
• 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

Study Sites (1)

Erasmus MC

Rotterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Glioma

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Study Officials

• Alejandra Mendez Romero, MD PhD

  Assitant Professor, Radiation Oncologist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven HJ Nagtegaal, MD PhD

CONTACT

+31(0)107042249; s.nagtegaal@erasmusmc.nl

Alejandra Mendez Romero, MD PhD

CONTACT

+31(0)107035829; a.mendezromero@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 22, 2023
• Study Start: May 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: November 1, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)