To hear about similar clinical trials, please enter your email below
Trial Title:
Biopsy Versus Resection in Elderly Glioblastoma Patients. A Prospective Cohort Study.
NCT ID:
NCT05641220
Condition:
Glioblastoma
Conditions: Official terms:
Glioblastoma
Conditions: Keywords:
Glioblastoma
High grade glioma
Surgical management
Biopsy
Resection
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Summary:
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.
Criteria for eligibility:
Study pop:
Adults with presumed Glioblastoma on first diagnostic MRI-scan.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
1. Age ≥70 years
2. 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.
3. Karnofsky Performance Score (KPS) ≥70
4. Written Informed consent
Exclusion Criteria:
1. Tumors of the cerebellum, brain stem or midline
2. Multifocal contrast enhancing lesions
3. Substantial non-contrast enhancing tumor areas suggesting low grade gliomas with
malignant transformation
4. Medical reasons precluding MRI (e.g. pacemaker)
5. Inability to give consent as assessed by neurosurgeon (e.g. language barrier)
6. Severe aphasia prohibiting neurolinguistic testing and comprehension of informed
consent
7. Previous brain tumor surgery
8. Previous low-grade glioma
9. 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.
Gender:
All
Minimum age:
70 Years
Maximum age:
95 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Northwest Clinics
Address:
City:
Alkmaar
Country:
Netherlands
Contact:
Last name:
Lesley E. Kwee, Drs.
Email:
le.kwee@nwz.nl
Facility:
Name:
Haaglanden MC
Address:
City:
Den Haag
Country:
Netherlands
Contact:
Last name:
Marieke L.D. Broekman
Email:
m.broekman@haaglandenmc.nl
Facility:
Name:
Medical Spectrum Twente
Address:
City:
Enschede
Country:
Netherlands
Contact:
Last name:
Kuan H. Kho, Drs.
Email:
k.kho@mst.nl
Facility:
Name:
Maastricht UMC
Address:
City:
Maastricht
Country:
Netherlands
Contact:
Last name:
Koos Hovinga, Dr.
Email:
koos.hovinga@mumc.nl
Facility:
Name:
Erasmus MC
Address:
City:
Rotterdam
Country:
Netherlands
Contact:
Last name:
Arnaud J.P.E. Vincent, Prof. Dr.
Email:
a.vincent@erasmusmc.nl
Facility:
Name:
Elisabeth-TweeSteden Hospital
Address:
City:
Tilburg
Country:
Netherlands
Contact:
Last name:
Geert-Jan J.M. Rutten, Dr.
Email:
g.rutten@etz.nl
Start date:
January 1, 2023
Completion date:
January 1, 2027
Lead sponsor:
Agency:
Erasmus Medical Center
Agency class:
Other
Source:
Erasmus Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05641220
