Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01413438 : Bevacizumab With or Without Surgery for Adult Glioblastomas
PhasePhase 2
AgesMin: 18 Years Max: N/A
Eligibility
- INCLUSION CRITERIA:

Previous diagnosis of supratentorial GBM established by WHO histological criteria

Age 18 or older

NRGS score of 0 to 2 established by the following criteria:

- KPS 80 or less (1 point)

- Tumor volume 50 cc or greater (1 point)

- Tumor involvement of at least 2 of the following brain areas (1 point):

- Motor cortex

- Language cortex

- Areas directly adjacent to the proximal (M1 and/or M2) middle cerebral artery

Received initial treatment for GBM with:

- External beam radiation therapy

- Nitrosourea or temozolomide chemotherapy

- Biopsy, subtotal or gross total resection

Evidence of recurrence, defined as the appearance or enlargement since previous imaging of
a contrast-enhancing mass on T1-weighted MRI

Have a non-deep (involving basal ganglia, thalamus, or periventricular region),
non-diffuse recurrence judged to be resectable by a neurosurgeon

Able to provide informed consent

EXCLUSION CRITERIA:

NRGS score of 3

Patients requiring biopsy only or other procedures where the goal is not tumor
cytoreduction

Patients who require urgent or emergency surgery due to symptoms of raised intracranial
pressure or herniation

Patients who have already received bevacizumab therapy

Contraindication to surgery as determined by a neurosurgeon, including bleeding diathesis,
unacceptable pulmonary or cardiovascular risk, significant wound healing concerns, or
tumor recurrence judged to be inoperable, inaccessible, or diffuse

Contraindication to bevacizumab as determined by a neuro-oncologist, including
unacceptable end organ function, evidence of acute intracranial hemorrhage, or recent or
active use of anticoagulants

Contraindication to MRI scanning as determined by a radiologist, including pacemakers or
other implanted electrical devices, brain stimulators, some types of dental implants,
aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including
metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted
delivery pump, or shrapnel fragments

Pregnancy
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01413438      |      Link to official Clinicaltrials.gov listing
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