Glioma, IDH mutated, Grade 2 and 3.
Conditions
Interventions
This study protocol proposes an observational cohort of IDHmG patients undergoing standard radiotherapy and chemotherapy routinely used for IDH mutated glioma, WHO grade 2 and 3. There is no investiga
Sponsors
ErasmusMC
Eligibility
Inclusion criteria
Inclusion criteria: - Age > 18 years - Histologically confirmed glioma, WHO grade 2 or 3, IDH1/2 mutated - Indication for standard treatment with radiotherapy and chemotherapy --- For WHO grade 2 tumors 50.4 Gy (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 con-sent, as determined by the treating physician. - Written informed consent.
Exclusion criteria
Exclusion criteria: - 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 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 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. comple-tion of questionnaires or neurocognitive performance)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hopkins Verbal Learning Test – delayed recall condition, change from baseline. Toxicity, as evaluated by CTCAE4.03 criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| Neuropsychological tests (HVLT-R, TMT A and B, COWA, MOS Cognitive Functioning Scale, DIMA), Next intervention free survival, Progression free survival, Overall survival, Quality of Life questionnaires (EORTC QLQ-C30, BN20, EQ5d-5L), Health-related Economics questionnaires (iMCQ and iPCQ). | — |
Contacts
Public ContactJaap Jaspers
Erasmus MC
Outcome results
None listed