Comparing awake craniotomy and general anesthesia for glioblastoma surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter randomized controlled trial aims to evaluate the safety and efficacy of awake craniotomy versus surgery under general anesthesia in patients with Glioblastoma Multiforme located in eloquent brain areas. A total of 246 patients will be randomized into two groups: one undergoing awake craniotomy with cortical and subcortical stimulation, and the other receiving surgery under general anesthesia. The primary endpoints include the proportion of patients experiencing neurological deterioration post-surgery and the extent of tumor resection achieved. The study seeks to improve surgical outcomes and quality of life for patients with this aggressive brain tumor.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 years and ≤ 90 years
2. Tumor diagnosed as Glioblastoma Multiforme on MRI with distinct ring-like pattern of contrast enhancement with thick irregular walls and a core area reduced signal suggestive of tumour necrosis as assessed by the surgeon
3. Tumors situated in or near eloquent areas; motor cortex, sensory cortex, subcortical pyramidal tract or speech areas as indicated on MRI (Sawaya Grading II and II)
4. The tumor is suitable for resection (according to neurosurgeon)
5. Karnofsky performance scale 80 or more
6. 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 (eg, pacemaker)
5. Inability to give consent because of or language barrier
6. Psychiatric history
7. Previous brain tumour 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.
10. Severe aphasia or dysphasia

Where it's running

• University Hospital Ghent
  Ghent, Belgium Recruiting
• Elisabeth-Tweesteden Ziekenhuis
  Tilburg, North Brabant, Netherlands Recruiting
• Erasmus MC
  Rotterdam, South Holland, Netherlands Recruiting
• Medical Center Haaglanden
  The Hague, South Holland, Netherlands Recruiting
• University Medical Center Groningen
  Groningen, Netherlands Recruiting

Study contacts

• Principal investigator: Arnaud Vincent, MD PhD — Erasmus Medical Center
• Study coordinator: Jasper Gerritsen, MD PhD
• Email: j.gerritsen@erasmusmc.nl
• Phone: +31629119553

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Adding ruxolitinib to standard radiation and temozolomide for newly diagnosed glioblastoma

  This trial will try whether adding the oral drug ruxolitinib to standard radiation and temozolomide helps adults newly diagnosed with glioblastoma.

  Recruiting at 2 sites Phase 2 Baptist Health South Florida · Miami, Florida and 1 other locations · NCT06991101

• Using omental tissue to treat recurrent glioblastoma

  This study is testing whether using a piece of fat from the abdomen can help improve treatment for patients with recurrent glioblastoma by delivering medication and immune cells more effectively to the tumor site.

  Recruiting Northwell Health · New York, New York · NCT05979064

• Gene therapy combined with radiotherapy for brain tumors

  This study is testing a new gene therapy combined with targeted radiation to see if it can safely help people with recurrent high-grade brain tumors.

  Recruiting Phase 1 Henry Ford Health System · Detroit, Michigan · NCT05686798

• Home-based self-management and cognitive training for brain tumor survivors

  This trial will try a home-based cognitive coaching program to see if it improves thinking and quality of life for adults who survived non-glioblastoma brain tumors, with optional caregiver participation.

  Recruiting Dartmouth-Hitchcock Medical Center · Lebanon, New Hampshire · NCT06930846

• Combining TIL Therapy and Pembrolizumab for Advanced Brain Cancer

  This study is testing a new treatment that combines a type of immune therapy using patients' own tumor cells with Pembrolizumab to see if it helps people with advanced brain cancer feel better and live longer.

  Recruiting Phase 1/2 Essen Biotech · Beijing, Beijing Municipality · NCT06640582

• Evaluating Bevacizumab with Focused Ultrasound for Recurrent Glioblastoma

  This study is testing if adding focused ultrasound to the standard treatment of Bevacizumab can help people with recurrent glioblastoma feel better and live longer.

  Recruiting at 2 sites Phase 3 NaviFUS Corporation · Taipei and 1 other locations · NCT06496971

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.