C71.9
Conditions
Interventions
Group 1: Microsurgical tumour resection (with surgical aim of complete removal of CE-lesion).
The participation in the study does not influence the tumour treatment at all. In addition to the regular
Sponsors
Uniklinik Köln, Zentrum für Neurochirurgie
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - contrast-enhancing cerebral tumor (suspection: glioblastoma): first diagnosed, supratentorial, unilateral, single lesion (no further intracerebral tumors) - age > 18 yrs - written informed consent - good clinical state (KPS 70 or better, i.e., independent in basic daily life)
Exclusion criteria
Exclusion criteria: - infratentorial, multiple or bihemispheric cerebral tumors (according to CE-T1), gliomatosis cerebri - previous brain radiation therapy - chemotherapy within 2 yrs prior to inclusion - non-controlled epilepsy (despite anticonvulsive drugs > 3 focal seizures per day or > 1 generalized seizure within 3 days prior to 1st neurocognitive testing). - abuse of drugs which may alter neurocognitive functioning (incl. alcohol) other than regular pain killers or regular anticonvulsive treatment 30 / 63 pts or acute/decompensated psychiatric disorder) - severe dementia (Mini Mental State Test [MMST] < 20 / 30 pts.) - institutionalised patients - contraindications regarding exposition to magnetic fields (MRI scan), e.g. metallic devices
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alterations of neurocognitive functioning after brain tumour resection (vs. stereotactic biopsy). Herefore, changes of the individual test performance after surgery as compared to before surgery are assessed as changes in the test score values in % (individual level). Assessment at time points 1 vs. 3 (before surgery vs. after surgery = before discharge). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Alterations of neurocognitive functioning following radiochemotherapy (individual level in %; see primary endpoint) - Assessment at visits 3 & 4. 2. Test-parallel-test-reliability of neurocognitive function assessment in glioblastoma patients (individual level; score values of each test) - Assessment at visits 2 & 3. 3. Correlation of neurocognitive deficits with tumour / oedema location (T-Scores of each test; lesion symptom mapping) - Assessment at visits 1, 3 & 4. 4. Quality of life (SF-12 Score value) - Assessment at visits 1 & 4. 5. Depression (BDI Score value) - Assessment at visits 1 & 4. Visits: (1) before surgery, (2/3) after surgery / before discharge, (4) +/- 3 months after surgery | — |
Countries
Germany
Contacts
Public ContactSophia; Kochs;
Uniklinik Köln, Allgemeine Neurochirurgie;Uniklinik Köln, Allgemeine Neurochirurgie
Outcome results
None listed