Comparing Biopsy and Surgical Removal for Older Adults with Brain Tumor
Compares biopsy and tumor removal in older adults with newly diagnosed glioblastoma, a brain cancer.
Plain-language title generated from the registry record
Registry title: Biopsy Versus Resection in Elderly Glioblastoma Patients. A Prospective Cohort Study.
Key facts
- Where
- Alkmaar, Enschede, Maastricht, Rotterdam, The Hague, and Tilburg, NetherlandsSee the 6 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 70 and 95 years old?
Source: NCT05641220, who can take part
Where in Netherlands
- Northwest ClinicsAlkmaar, NetherlandsNo longer taking part
- Medical Spectrum TwenteEnschede, NetherlandsNo longer taking part
- Maastricht UMCMaastricht, NetherlandsNo longer taking part
- Erasmus MCRotterdam, NetherlandsNo longer taking part
- Haaglanden MCThe Hague, NetherlandsNo longer taking part
- Elisabeth-TweeSteden HospitalTilburg, NetherlandsNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Erasmus Medical Center
- Trial code
- NCT05641220
- Record updated
- 7 December 2022
- Original description
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.Read full original descriptionShow less
Biopsy Versus Resection in Elderly Glioblastoma Patients. A Prospective Cohort Study.
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.
Inclusion: Age ≥70 years; Tumor diagnosed as glioblastoma on MRI with distinct ring-like pattern of contrast enhancement with thick irregular walls and a core area reduced signal suggestive of tumor necrosis as assessed by the surgeon; Karnofsky Performance Score (KPS) ≥70; Written Informed consent.
Exclusion: Previous brain tumor surgery; Previous low-grade glioma; Substantial non-contrast enhancing tumor areas suggesting low grade gliomas with malignant transformation; Second primary malignancy within the past 5 years with the exception of adequately treated in situ carcinoma of any organ or basal cell carcinoma of the skin; Tumors of the cerebellum, brain stem or midline; Multifocal contrast enhancing lesions; Medical reasons precluding MRI (e.g. pacemaker); Inability to give consent as assessed by neurosurgeon (e.g. language barrier); Severe aphasia prohibiting neurolinguistic testing and comprehension of informed consent.