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Bevacizumab versus bevacizumab plus lomustine versus lomustine in recurrent glioblastoma.

Recruiting
Conditions
recurrent glioblastoma
bevacizumab
lomustine
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
NameTimeMethod
9 month overall survival (9 mo OS).
Secondary Outcome Measures
NameTimeMethod
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.
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