The purpose of this study is to explore the efficacy of bevacizumab combined with
radiotherapy compared with radiotherapy alone in the treatment of newly diagnosed
glioblastoma in the elderly.
- Trial with medicinal product
Radiation: Radiation therapy
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Locations near you
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Full eligibility criteria for NCT01443676
Ages eligible for Study
65 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
newly diagnosed glioblastoma in elderly patients
Signed informed consent
Age > 65 years
Newly diagnosed supratentorial glioblastoma
Eligible for first infusion of bevacizumab > 28 and > 49 days after surgery for glioblastoma
Karnofsky performance score 60 or more
Paraffin-embedded tissue for central pathology review
Stable or decreasing corticosteroid dose within 5 days prior to enrolment
Adequate haematological function:
Adequate liver function
Adequate renal function
Karnofsky performance score 50 or less
Evidence of recent hemorrhage on postoperative brain MRI
Tumor with infiltration of retina, optic nerve, optic chiasm or brainstem
Any prior chemotherapy including carmustine-containing wafers (Gliadel®) or immunotherapy for glioblastoma or lower grade astrocytomas
Any prior radiotherapy to the brain or prior radiotherapy resulting in a potential overlap in the radiation field
Inadequately controlled hypertension
History of hypertensive crisis or hypertensive encephalopathy
New York Heart Association (NYHA) grade II or higher congestive heart failure
Myocardial infarction or unstable angina within 6 months prior to enrolment
Stroke or transitory ischemic attack within 6 months prior to enrolment
Other significant vascular disease within 6 months prior to enrolment
History of = grade 2 haemoptysis within 1 month prior to enrolment
Bleeding diathesis or coagulopathy in the absence of therapeutic anticoagulation
Major surgical procedure, open biopsy, intracranial biopsy, ventriculoperitoneal shunt or significant traumatic injury within 28 days prior to first dose of bevacizumab
Core biopsy (excluding intracranial biopsy) or other minor surgical procedure within 7 days prior to first dose of bevacizumab
Abdominal fistula or gastrointestinal perforation within 6 months prior to enrolment
Intracranial abscess within 6 months prior to enrolment
Serious non-healing wound, active ulcer or untreated bone fracture
Pregnancy or lactation
Fertile women < 2 years after last menstruation and men unwilling or unable to use effective means of contraception
Active malignancy that may interfere with the study treatment at the investigator?s and PI discretion
All locations for NCT01443676
Department of Neurology, University Hospital Zurich
View full eligibility
Tris trial is registered with FDA with number: NCT01443676. The sponsor of the trial is University of Zurich and it is looking for 75 volunteers for the current phase.
Official trial title: Avastin Plus Radiotherapy in Elderly Patients With Glioblastoma
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