The PROGRAM-study: Awake Mapping Versus Asleep Mapping Versus No Mapping for Glioblastoma Resections

Обзор

The study is designed as an international, multicenter prospective cohort study. Patients with presumed glioblastoma (GBM) in- or near eloquent areas on diagnostic MRI will be selected by neurosurgeons. Patients will be treated following one of three study arms: 1) a craniotomy where the resection boundaries for motor or language functions will be identified by the "awake" mapping technique (awake craniotomy, AC); 2) a craniotomy where the resection boundaries for motor functions will be identified by "asleep" mapping techniques (MEPs, SSEPs, continuous dynamic mapping); 3) a craniotomy where the resection boundaries will not be identified by any mapping technique ("no mapping group"). All patients will receive follow-up according to standard practice.

Вмешательства

• Процедура Awake mapping under local anesthesia
  During an awake craniotomy, the patient is awake and cooperative during the resection of the tumor while the surgeon uses electro(sub)cortical mapping to prevent damage to eloquent areas.
• Процедура Asleep mapping under general anesthesia
  During asleep mapping under general anesthesia, the surgeon uses electro(sub)cortical mapping with evoked potentials (MEPs, SSEPs or continuous dynamic mapping) to prevent damage to eloquent areas.
• Процедура Resection under general anesthesia without mapping
  During resection under general anesthesia without mapping, the surgeon does not use any intraoperative stimulation mapping techniques to identify eloquent areas.

Первичные конечные точки

• Neurological morbidity [Срок оценки: Between baseline and 6 weeks/3 months/6 months postoperatively]
• Extent of resection [Срок оценки: Assessed within 72 hours on postoperative MRI scan]

Вторичные конечные точки (6)

• Progression-free survival [Срок оценки: Between surgery and 12 months postoperatively]
• Overall survival [Срок оценки: Between surgery and 12 months postoperatively]
• Onco-functional outcome [Срок оценки: Between baseline and 6 weeks/3 months/6 months postoperatively]
• Frequency and severity of Serious Adverse Events (SAEs) [Срок оценки: Between surgery and 6 weeks postoperatively]
• Residual tumor volume [Срок оценки: Assessed within 72 hours on postoperative MRI scan]
• MRC deterioration (for motor gliomas) [Срок оценки: Between baseline and 6 weeks/3 months/6 months postoperatively]

Критерии участия

Критерии включения

• Age ≥18 years and ≤ 90 years
• Tumor diagnosed as GBM on MRI as assessed by the neurosurgeon
• Tumors situated in or near eloquent areas; motor cortex, sensory cortex, subcortical pyramidal tract, speech areas or visual areas as indicated on MRI (Sawaya Grading II and II)
• The tumor is suitable for resection (according to neurosurgeon)
• Written informed consent

Критерии исключения

• Tumors of the cerebellum, brain stem or midline
• Multifocal contrast enhancing lesions
• Medical reasons precluding MRI (e.g. pacemaker)
• Inability to give written informed consent (e.g. because of severe language barrier)
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 2 центра

• University of California, San Francisco — San Francisco
• Massachusetts General Hospital — Boston

Германия · 2 центра

• University Hospital Heidelberg — Heidelberg
• Technical University Munich — Munich

Нидерланды · 2 центра

• Erasmus MC — Rotterdam
• Medical Center Haaglanden — The Hague

Бельгия · 1 центр

• University Hospitals Leuven — Leuven

Швейцария · 1 центр

• Inselspital Universitätsspital Bern — Bern

Публикации

• Gerritsen JKW, Zwarthoed RH, Kilgallon JL, Nawabi NL, Jessurun CAC, Versyck G, Pruijn KP, Fisher FL, Lariviere E, Solie L, Mekary RA, Satoer DD, Schouten JW, Bos EM, Kloet A, Nandoe Tewarie R, Smith TR, Dirven CMF, De Vleeschouwer S, Broekman MLD, Vincent AJPE. Effect of awake craniotomy in glioblastoma in eloquent areas (GLIOMAP): a propensity score-matched analysis of an international, multicent PMID 35569489
• Gerritsen JKW, Dirven CMF, De Vleeschouwer S, Schucht P, Jungk C, Krieg SM, Nahed BV, Berger MS, Broekman MLD, Vincent AJPE. 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. BMJ Open. 2021 Jul 21;11(7):e047306. doi: 10.1136/bmjopen-2020-047306. PMID 34290067

Идентификаторы

NCT: NCT04708171 · MEC-2020-081-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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