Status:
COMPLETED
Avastin Plus Radiotherapy in Elderly Patients With Glioblastoma
Lead Sponsor:
University of Zurich
Conditions:
Glioblastoma
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief Summary
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. * Tria...
Detailed Description
This is a randomized (2:1), explorative, parallel-group, open-label, phase II trial in elderly patients with newly diagnosed glioblastoma. In the control arm, patients will receive radiotherapy, in th...
Eligibility Criteria
Inclusion
- Inclusion criteria: Diagnosis: 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
- Exclusion criteria:
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01443676
Start Date
October 1 2011
End Date
August 1 2016
Last Update
November 1 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Neurology, University Hospital Zurich
Zurich, Switzerland