The SAFE-Trial: Awake Craniotomy Versus Surgery Under General Anesthesia for Glioblastoma Patients.

Launched by JASPER GERRITSEN · Mar 1, 2019

Keywords

ClinConnect Summary

The SAFE-Trial is a clinical study comparing two types of brain surgery for patients with glioblastoma, a type of aggressive brain cancer. The study will involve 246 patients who have tumors located in critical areas of the brain that control important functions like movement and speech. These patients will be randomly assigned to undergo either an awake craniotomy, where they are conscious during the surgery, or traditional surgery under general anesthesia, where they are fully asleep. The aim is to see which method allows for safer and more effective tumor removal while preserving vital functions.

To be eligible for this trial, participants must be between 18 and 90 years old, have a confirmed diagnosis of glioblastoma, and have tumors that are suitable for surgical removal. They must also have a good level of daily functioning. If a patient is not confirmed to have glioblastoma following surgery, they will be withdrawn from the study but will still receive standard follow-up care. After the surgery, all participants will receive additional treatment with chemotherapy and radiation. This study will last for five years, with patient recruitment expected to take four years and a follow-up period of one year after surgery.

Gender

ALL

Eligibility criteria

• 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