Bevacizumab versus bevacizumab plus lomustine versus lomustine in recurrent glioblastoma.
Recruiting
- Conditions
- recurrent glioblastomabevacizumablomustine
- Registration Number
- NL-OMON27373
- Lead Sponsor
- Erasmus MC - Daniel den HoedProf. Dr. M.J. van den Bent, MD PhD Neuro-OncologistDrs. W. Taal, MD Neuro-Oncologist
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 144
Inclusion Criteria
1. Age ≥ 18 years;
2. WHO Performance status 0 - 2;
Exclusion Criteria
1. History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding;
2. Arterial or venous thrombosis ≤ 12 months prior to registration;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 9 month overall survival (9 mo OS).
- Secondary Outcome Measures
Name Time Method 1. Objective response rate;<br /><br>2. Median PFS;<br /><br>3. PFS at 6 months and 12 months;<br /><br>4. Median Overall Survival (OS);<br /><br>5. OS at 6 and 12 months;<br /><br>6. Toxicity;<br /><br>7. Neurological deterioration free survival;<br /><br>8. Quality of Life;<br /><br>9. Steroid use.<br /><br>Response will only be assessed in patients with measurable disease.