Status:
COMPLETED
Radiotherapy in IDH Mutated Glioma: Evaluation of Late Outcomes
Lead Sponsor:
Erasmus Medical Center
Collaborating Sponsors:
HollandPTC
Amsterdam University Medical Center
Conditions:
Astrocytoma, Grade II
Astrocytoma, Grade III
Eligibility:
All Genders
18+ years
Brief 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 le...
Eligibility Criteria
Inclusion
- Histologically confirmed glioma, World Health Organisation (WHO) grade 2 or 3, IDH mutated
- Indication for standard treatment with radiotherapy and chemotherapy. For WHO grade 2 tumors 50.4 Gy relative biological equivalent (RBE) in 28 fractions. For WHO grade 3 tumors 59.4 Gy (RBE) in 33 fractions.
- Ability to comply with the protocol, including neuropsychological testing and imaging.
- Ability to understand the requirements of the study and to give written informed consent, as determined by the treating physician.
- Written informed consent.
Exclusion
- Any prior chemotherapy for IDHmG. This includes upfront postoperative chemotherapy.
- Any prior cranial radiotherapy, including but not limited to radiotherapy for IDHmG.
- Prior invasive malignancy, except non-melanoma skin cancer, completely resected cervical or prostate cancer (with current prostate specific antigen (PSA) of less than or equal to 0.1 ng/mL).
- Extensive white matter disease visible on pre-therapy imaging (Fazekas grade ≥2)
- Contra-indication for magnetic resonance (MR) imaging (i.e. metal implants, claustrophobia)
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule in the participating hospitals
- Any other serious medical condition that could interfere with follow-up.
- Severe aphasia or language barrier interfering with assessing endpoints (i.e. completion of questionnaires or neurocognitive performance)
Key Trial Info
Start Date :
December 10 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 15 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04304300
Start Date
December 10 2019
End Date
June 15 2024
Last Update
October 15 2024
Active Locations (5)
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1
Erasmus MC
Rotterdam, South Holland, Netherlands, 3015 CE
2
Amsterdam UMC
Amsterdam, Netherlands, 1081 HV
3
HollandPTC
Delft, Netherlands, 2629 JH
4
Leiden University Medical Center
Leiden, Netherlands, 2333 ZA