Status:
WITHDRAWN
Bevacizumab With or Without Surgery for Adult Glioblastomas
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Glioblastoma
Brain Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Background: \- Glioblastoma (GBM) is the most common malignant brain tumor in adults. Patients with GBM are usually treated with surgery, radiation, and chemotherapy. Despite this treatment, most GBM...
Detailed Description
Objective The objective of this prospective randomized controlled study is to determine the overall survival benefit of tumor resection in patients with recurrent glioblastoma multiforme (GBM). Stud...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 15 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01413438
Start Date
July 15 2011
End Date
September 26 2013
Last Update
July 2 2017
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