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Radiotherapy in IDH Mutated Glioma: Evaluation of Late Outcomes

NCT04304300 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2024-10-15

No results posted yet for this study

Summary

Rationale: Standard postoperative treatment of isocitrate dehydrogenase 1/2 mutated grade 2 and 3 glioma (IDHmG) consists of radiotherapy and chemotherapy. The improving prognosis of these patients leads towards more emphasis on the long-term effects of treatment. Specifically radiotherapy has been implicated in the development of delayed neurocognitive deterioration. The impact of modern radiotherapy techniques (such as intensity modulated radiotherapy, volumetric modulated radiotherapy and proton beam therapy) and chemotherapy on general toxicity, late neurocognitive outcomes and imaging changes is currently unclear.

Objectives:

* To report treatment outcomes and radiation-induced toxicity from a prospective, multicentre observational cohort of IDHmG patients treated with radiotherapy and chemotherapy,
* To integrate radiotherapeutic dose distributions, imaging changes and neuropsychological outcome in IDHmG.
* To evaluate the Dutch selection criteria for proton therapy applied to IDHmG based on the outcomes collected in this observational study.
* To assess the impact of proton and photon therapy on health-related quality of life (HRQoL) and health-related economics (HR-E) in IDHmG patients.
* To collect genetic material for future translational research into the interaction between germline DNA, prognosis and radiation-induced toxicity.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This project is a multicentre, observational cohort of patients undergoing radiotherapy and chemotherapy for IDHmG. The protocol closely follows the local guidelines for clinical follow-up. Specific to the study are extra questionnaires and specific imaging acquired during scheduled MRI's. Routine neuropsychological investigation is standard of care in Erasmus Medical Center (Erasmus MC), but not in all participating centers. We feel the additional burden of participation in this study to be low.

Conditions

  • Astrocytoma, Grade II
  • Astrocytoma, Grade III
  • Oligodendroglioma
  • Oligodendroglioma, Anaplastic

Sponsors & Collaborators

  • HollandPTC

    collaborator INDUSTRY

  • Amsterdam University Medical Center

    collaborator OTHER

  • Leiden University Medical Center

    collaborator OTHER

  • Delft University of Technology

    collaborator OTHER

  • Medical Center Haaglanden

    collaborator OTHER

  • Erasmus Medical Center

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-10
Primary Completion
2024-06-15
Completion
2024-06-15

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04304300 on ClinicalTrials.gov