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The PROGRAM-study: Awake Mapping versus Asleep Mapping versus No Mapping for Glioblastoma Resections: Study Protocol for An International Multicenter Prospective 3-Arm Non-Randomized Clinical Trial

The PROGRAM-study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON25963
Enrollment
453
Registered
2020-10-23
Start date
2021-02-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma

Interventions

Awake mapping (awake craniotomy) Asleep mapping

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

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

Design outcomes

Primary

MeasureTime frame
Postoperative neurological complications; extent of resection

Secondary

MeasureTime frame
Overall survival; progression-free survival; onco-functional outcome

Contacts

Public ContactJasper Gerritsen

Erasmus MC

j.gerritsen@erasmusmc.nl+31629119553

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)