Glioma IDH mutated. Glioma low grade (WHO 2) and anaplastic (WHO 3) brain tumor
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age > 18 years - Resection (any grade) or biopsy of one of the following: glioma, WHO grade 2 or 3, IDH mutated - Indication and fit for standard treatment with radiotherapy and chemotherapy o For WHO grade 2 tumors 50.4 Gy (RBE) in 28 fractions. o For WHO grade 3 tumors 59.4 Gy (RBE) in 33 fractions. - Ability to comply with the protocol, including neuropsychological testing and imaging, as judged by the local investigator. - Ability to understand the requirements of the study and to give written informed consent. - Written informed consent.
Exclusion criteria
Exclusion criteria: - Any prior cranial radiotherapy. - Prior or second invasive malignancy, except non-melanoma skin cancer, completely resected cervical or prostate cancer (with 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. - Aphasia or language barrier interfering with endpoints and questionnaires (i.e. assessment of QoL, neurocognitive performance)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters/endpoints: • Next intervention free survival during follow-up. • Freedom of neuropsychological decline during follow-up, defined as a significant decline in performance in one of the following neuropsychological tests: Hopkins Verbal Learning test, Trail making test, Controlled Oral Word Association and Dutch Language Interoperative Protocol. • Toxicity evaluated with CTCAE - 5.0 | — |
Secondary
| Measure | Time frame |
|---|---|
| • MRI changes during follow up. • Quality of life, as measured by QLQ-C30, BN20 and EQ5D. • Health economics, as measured by the Productivity Cost Questionnaire and Medical Consumption Questionaire. | — |
Countries
Netherlands
Contacts
Public ContactA.M. Mendez Romero
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed