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This trial is set up as a prospective observational cohort study to identify if either biopsy or resection should be the surgical modality of choice in elderly glioblastoma patients with a newly diagnosed tumor. Patients who are considered eligible for GBM resection or biopsy will be included. Through shared-decision making patients and their treating physicians will decide upon resection or biopsy. Written informed consent will be obtained. Participants will be followed for 1 year postoperative to assess potential differences in health-related quality of life and overall survival.
Follow-up will consist of health-related quality of life questionaires and neurological assessment at 6 weeks, 3 months, 6 months and 12 months postoperative. Additionally Cognitive and neuro-linguistic tests will be done at 3 months postoperative. These will be compared to results pre-operative.
After surgery, patients will receive standard adjuvant treatment with concomitant Temozolomide and radiation therapy, and standard follow-up. Patients in whom the diagnosis GBM is not confirmed in histological analyses will be excluded from the study. Total study duration will be 4 years, of which 3 years will comprise patient inclusion, with a follow-up duration of 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biopsy | Newly diagnosed elderly (>70 years of age) glioblastoma patients who undergo biopsy | ||
| Resection | Newly diagnosed elderly (>70 years of age) glioblastoma patients who undergo resection |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Defined as the time from diagnosis to the death of the patient from any cause | 12 months |
| The difference in mean change score of physical functioning, as measured with the EORTC QLQ-C30 physical functioning scale, between the two groups at 6 weeks and 3 months after surgery compared to mean score on baseline | Measured with the European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire (EORTC QLQ-C30), a higher scores means a worse outcome. We assume a minimally important difference of 7 between the 2 groups. | 6 weeks and 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS), defined as the time from diagnosis to disease progression | Increase in residual tumor volume of more than 25%, or occurrence of a new tumor lesion with a volume greater than 0.175cm3), or death. As according to the RANO criteria. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with presumed Glioblastoma on first diagnostic MRI-scan.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yvette de Haan, drs | Contact | +31612594000 | y.dehaan@erasmusmc.nl | |
| Arnaud J.P.E. Vincent, Prof. Dr. | Contact | a.vincent@erasmusmc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Arnaud J.P.E. Vincent, Prof. Dr. | Erasmus MC, department of neurosurgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwest Clinics | Alkmaar | Netherlands |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D005910 | Glioma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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| The difference in mean change score of physical functioning, as measured with the EORTC QLQ-C30 physical functioning scale, between the two groups at 6 months and 12 months after surgery compared to mean score on baseline. | Measured with the European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire (EORTC QLQ-C30), a higher scores means a worse outcome. | at 6 months and 12 months after surgery |
| The proportion of patients with deterioration, improvement or stable physical functioning, as measured with the EORTC QLQ-C30 physical functioning scale at 6 weeks and 3 months compared to baseline. | Measured with the European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire (EORTC QLQ-C30), a higher scores means a worse outcome. | 6 weeks and 3 months after surgery |
| Descriptive reporting of changes in the mean scores on the other health-related quality of life (HRQoL) scales at 6 weeks and 3 months after surgery. | HRQoL will be measured using the Measured with the European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life questionnaire (QLQ-C30), EORTC , EORTC brain cancer module (QLQ-BN20) and EuroQol 5 Dimensions (EQ-5D) questionnaires. A higher scores means a worse outcome. | at 6 weeks and 3 months postoperative |
| Proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration, improvement or stability at 6 weeks and 3 months after surgery | In which deterioration is defined as an increase of at least one point and improvement as a decrease of at least one point on the total NIHSS score compared to this score at baseline. | at 6 weeks and 3 months postoperative |
| Descriptive reporting of differences between the groups in cognitive and neuro-linguistic screening at 3 months compared to baseline. | as measured by the Aphasia Bedside Check (ABC), Shortened Token Test, verbal fluency (category and letter), Montreal Cognitive Assessment (MOCA) and optionally CAT-NL Picture Description and Object Naming. | 3 months postoperative |
| Comparison of the (S)AEs in both groups. | 6 weeks postoperative |
| Cost-effectiveness between the two treatments. | Measured as total intramural medical costs, for a 1 year time horizon | 12 months postoperative |
| Medical Spectrum Twente | Enschede | Netherlands |
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| Maastricht UMC | Maastricht | Netherlands |
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| Erasmus MC | Rotterdam | Netherlands |
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| Haaglanden MC | The Hague | Netherlands |
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| Elisabeth-TweeSteden Hospital | Tilburg | Netherlands |
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| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |