Clinical trial NCT04708171: The PROGRAM-study: Awake Mapping Versus Asleep Mapping Versus No Mapping for Glioblastoma Resections
Official title: The PROGRAM-study: Awake Mapping Versus Asleep Mapping Versus No Mapping for Glioblastoma Resections
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glioblastoma
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Medical Center Haaglanden
name: Universitaire Ziekenhuizen KU Leuven
name: University of California, San Francisco
First posted: 2021-01-13
Enrollment: 453
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with primary or recurrent glioblastoma (GBM).

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years and ≤ 90 years
2. Tumor diagnosed as GBM on MRI as assessed by the neurosurgeon
3. 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)
4. The tumor is suitable for resection (according to neurosurgeon)
5. Written informed consent

Exclusion Criteria:

1. Tumors of the cerebellum, brain stem or midline
2. Multifocal contrast enhancing lesions
3. Medical reasons precluding MRI (e.g. pacemaker)
4. Inability to give written informed consent (e.g. because of severe language barrier)
5. 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

Primary outcomes:
measure: Neurological morbidity
timeFrame: Between baseline and 6 weeks/3 months/6 months postoperatively
measure: Extent of resection
timeFrame: Assessed within 72 hours on postoperative MRI scan
Secondary outcomes:
measure: Progression-free survival
timeFrame: Between surgery and 12 months postoperatively
measure: Overall survival
timeFrame: Between surgery and 12 months postoperatively
measure: Onco-functional outcome
timeFrame: Between baseline and 6 weeks/3 months/6 months postoperatively
measure: Frequency and severity of Serious Adverse Events (SAEs)
timeFrame: Between surgery and 6 weeks postoperatively
measure: Residual tumor volume
timeFrame: Assessed within 72 hours on postoperative MRI scan
measure: MRC deterioration (for motor gliomas)
timeFrame: Between baseline and 6 weeks/3 months/6 months postoperatively
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Leuven
country: Belgium
facility: University Hospitals Leuven
state: Vlaams-Brabant
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
city: Munich
country: Germany
facility: Technical University Munich
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Zuid-Holland
city: The Hague
country: Netherlands
facility: Medical Center Haaglanden
state: Zuid-Holland
city: Bern
country: Switzerland
facility: Inselspital Universitätsspital Bern
Study officials:
affiliation: Erasmus Medical Center
name: Jasper Gerritsen, MD
role: STUDY_DIRECTOR
References:
citation: 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, multicentre, cohort study. Lancet Oncol. 2022 Jun;23(6):802-817. doi: 10.1016/S1470-2045(22)00213-3. Epub 2022 May 12.
citation: 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.