Phase-III study of standard radiotherapy plus concomitant and adjuvant OSAG 101 (Theraloc®) plus Temozolomide vs. standard radiotherapy plus concomitant and adjuvant Temozolomide in patient with newly diagnosed, histologically confirmed glioblastoma multiforme grade IV
- Conditions
- Glioblastoma multiforme grade IV
- Registration Number
- EUCTR2005-003101-85-DE
- Lead Sponsor
- Oncoscience AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Each study patient must meet all of the following conditions:
•Investigator verifies patient's mental capacity to consent.
•Patient signed informed consent
•Histologically verified diagnosis of glioblastoma multiforme grade IV
•Age 18-70
•Karnofsky-Index >70
•Female patients with a childbearing potential must have a negative pregnancy test within one week before inclusion in the trial. Those female and male patients admitted in the study must use a reliable method of contraception (e.g. birth-control-pill, condom).
•Treatment in a study center
•Adequate haematological, renal and hepatic function according to the following definitions:
•Leucocytes >2.0x10 9/l
•Platelets = 50 x 10 9/l
•Hb > 10g/dl
•Billirubin total < 2.5x upper limit of normal (ULN)
•Creatinin i.S. < 1.5x ULN
•AST (GOT)/ALT (GPT) < 5x ULN
•Patients must be available during the treatment period and be able to comply with the study plan.
•MRI compatibility
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
None of the following conditions are permitted for a study patient:
•If investigator has any concerns regarding patient's mental condition or if patient is under disability, patient must not be randomized
•Previous participation in this study
•Prior chemotherapy or X-ray therapy or other experimental treatments during this study
•Participation in another therapeutic study involving the basic condition
•Females of childbearing age with insufficient or inadequately assured contraception
•Pregnancy or lactation
•Other existing serious conditions that could adversely affect the patient's therapy in accordance with the protocol
•Any other condition or therapy which in the opinion of the attending physician could represent a risk for the patient or interfere with study objectives
•Known contraindications against antibodies (e.g., prior treatment with recombinant/monoclonal antibodies)
•Missing or incomplete statement of consent
•Patients with evidence of second malignancy
•MRI not feasible
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Effectiveness of a humanized EGFR antibody for newly diagnosed histologically confirmed Glioblastoma multiforme grade IV ;Secondary Objective: ;Primary end point(s): -Progression-free survival determined by MRI
- Secondary Outcome Measures
Name Time Method