NCT03861299: SAFE

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

Recruiting now NA Last updated 21 November 2023

What this trial tests

NA trial testing Awake craniotomy in Glioblastoma in 246 participants. Currently enrolling.

Timeline

1 April 2019

Primary endpoint
1 September 2026

1 September 2027

Quick facts

Lead sponsor	Jasper Gerritsen
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	246
Start date	1 April 2019
Primary completion	1 September 2026
Estimated completion	1 September 2027
Sites	5 locations across Belgium, Netherlands

Drugs / interventions tested

• Awake craniotomy
• Craniotomy under general anesthesia

Conditions studied

• Glioblastoma — all drugs for Glioblastoma →
• Glioblastoma Multiforme — all drugs for Glioblastoma Multiforme →
• Glioblastoma Multiforme of Brain — all drugs for Glioblastoma Multiforme of Brain →
• Astrocytoma, Grade IV — all drugs for Astrocytoma, Grade IV →

Sponsor

Jasper Gerritsen

Who can join

Adults 18 to 90, any sex, with Glioblastoma or Glioblastoma Multiforme. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The trial is designed as a multicenter randomized controlled study. 246 patients with presumed Glioblastoma Multiforme in eloquent areas on diagnostic MRI will be selected by the neurosurgeons according the eligibility criteria (see under). After written informed consent is obtained, the patient will be randomized for an awake craniotomy (AC) (+/-123 patients) or craniotomy under general anesthesia (GA) (+/-123 patients), with 1:1 allocation ratio. Under GA the amount of resection of the tumour has to be performed within safe margins as judged by the surgeon during surgery. The second group will be operated with an awake craniotomy procedure where the resection boundaries for motor or language functions will be identified by direct cortical and subcortical stimulation. After surgery, the diagnosis of GBM will have to be histologically confirmed. If GBM is not histologically confirmed, patients will be considered off-study and withdrawn from the study. These patients will be followed-up according to standard practice. Thereafter, patients will receive the standard treatment with concomitant Temozolomide and radiation therapy and standard follow up. Total duration of the study is 5 years. Patient inclusion is expected to take 4 years. Follow-up is 1 year after surgery. Statistical analysis, cost benefit analysis and article writing will take 3 months.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of awake craniotomy in glioblastoma in eloquent areas (GLIOMAP): a propensity score-matched analysis of an international, multicentre, cohort study.
   Gerritsen JKW, Zwarthoed RH, Kilgallon JL, Nawabi NL, et al · · 2022 · cited 62× · PMID 35569489 · DOI 10.1016/s1470-2045(22)00213-3
2. Safe surgery for glioblastoma: Recent advances and modern challenges.
   Gerritsen JKW, Broekman MLD, De Vleeschouwer S, Schucht P, et al · · 2022 · cited 59× · PMID 36127890 · DOI 10.1093/nop/npac019
3. The surgical management of diffuse gliomas: Current state of neurosurgical management and future directions.
   Young JS, Morshed RA, Hervey-Jumper SL, Berger MS. · · 2023 · cited 26× · PMID 37499054 · DOI 10.1093/neuonc/noad133
4. The SAFE-trial: Safe surgery for glioblastoma multiforme: Awake craniotomy versus surgery under general anesthesia. Study protocol for a multicenter prospective randomized controlled trial.
   Gerritsen JKW, Klimek M, Dirven CMF, Hoop EO, et al · · 2020 · cited 19× · PMID 31676314 · DOI 10.1016/j.cct.2019.105876
5. Intraoperative glioblastoma surgery-current challenges and clinical trials: An update.
   Patel V, Chavda V. · · 2024 · cited 14× · PMID 39371095 · DOI 10.1016/j.cpt.2023.11.006
6. The PROGRAM study: awake mapping versus asleep mapping versus no mapping for high-grade glioma resections: study protocol for an international multicenter prospective three-arm cohort study.
   Gerritsen JKW, Dirven CMF, De Vleeschouwer S, Schucht P, et al · · 2021 · cited 12× · PMID 34290067 · DOI 10.1136/bmjopen-2020-047306
7. Technical Aspects of Motor and Language Mapping in Glioma Patients.
   Al-Adli NN, Young JS, Sibih YE, Berger MS. · · 2023 · cited 11× · PMID 37046834 · DOI 10.3390/cancers15072173
8. SUPRAMAX-study: supramaximal resection versus maximal resection for glioblastoma patients: study protocol for an international multicentre prospective cohort study (ENCRAM 2201).
   Gerritsen JKW, Young JS, Chang SM, Krieg SM, et al · · 2024 · cited 10× · PMID 38684246 · DOI 10.1136/bmjopen-2023-082274