Monocentric phase III clinical trial using citalopram (antidepressive compound fequently used in clinic) added to the standard of care (radio- combined with temozolomide chemotherapy and followed by temozolomide) for newly diagnosed glioblastoma patients (the most frequent malignant brain cancer) compared to the standard of care published in the literature
- Conditions
- ewly diagnosed glioblastoma (primary highly malignant brain cancer) patients Under treatmentTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-004705-59-BE
- Lead Sponsor
- Hôpital Erasme, ULB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Newly diagnosed glioblastoma
Signed informed consent
Age > = 18 years
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 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
Exclusion Criteria
Recurrent glioblastoma
Citalopram related exclusion criteria
Participation in another study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Phase III study comparing the standard of care radio- and temozolomide therapy for newly diagnosed glioblastoma patients (published in the literature) as compared to the same treatment adding citalopram each day 20 mg a day from the diagnosis to survival<br>Survival analysis;Secondary Objective: Quality of live comparison knowing that the treatment of depression during cancer therapy could increase quality of live and even survival <br>We will be helped by a psychiatrist practician;Primary end point(s): could citalopram added to the standard of care increase quality of live and survival of glioblastoma patients;Timepoint(s) of evaluation of this end point: survival
- Secondary Outcome Measures
Name Time Method Secondary end point(s): quality of live;Timepoint(s) of evaluation of this end point: quality of live questionnaire (EORTC) and with a psychiatric evaluation