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
- Conditions
- Glioblastoma
- Registration Number
- NL-OMON25963
- Lead Sponsor
- one
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 453
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
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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Postoperative neurological complications; extent of resection
- Secondary Outcome Measures
Name Time Method Overall survival; progression-free survival; onco-functional outcome
Related Research Topics
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