Newly-diagnosed Glioblastoma
Conditions
Keywords
Glioblastoma, Angiotensin-II inhibitors, Losartan, steroids, Radiotherapy, Edema, Randomized trial
Brief summary
To assess the efficacy of an Angiotensin-II inhibitor (Losartan) to reduce peritumoral edema in newly diagnosed glioblastoma patients.
Detailed description
Multicentre, randomized (1:1), double blinded trial:- Arm A: Standard of care (Radiotherapy with concomitant temozolomide followed by monthly cures of temozolomide ) + Losartan 50mg\*2/day until the halting for any reason - Arm B: Standard of care (Radiotherapy with concomitant temozolomide followed by monthly cures of temozolomide + Placebo 2/day until the halting for any reason.
Interventions
DRUGLosartan
Standard of care (Radiotherapy with concomitant temozolomide followed by monthly cures of temozolomide ) + Losartan or placebo (Arm A or B) 50mg\*2/day until the halting for any reason
DRUGPlacebo
Standard of care (Radiotherapy with concomitant temozolomide followed by monthly cures of temozolomide + Placebo 2/day until the halting for any reason
Sponsors
ANOCEF (french association of neuro-oncologists)
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * Histologically confirmed glioblastoma (Grade 4 WHO) * patients eligible for radiotherapy and concomitant Temozolomide * KPS ≥ 50% * Adequate hematologic, liver and renal functions
Exclusion criteria
* Patients unable to undergo an MRI with contrast * Patients without any residual tumor left on the screening MRI of both flair and contrast-enhanced lesions complete surgical resection) * Any prior treatment of glioblastoma including any local therapy (immunotherapy, Gliadel wafers, …..) during or after surgical resection * Any on-going treatment for high blood pressure at time of inclusion, whatever the therapeutic class of drugs * Systolic blood pressure \<110 mmHg. * relative or definite contra-indication to Losartan: * Pregnant or breast feeding women; Women with an intact uterus (unless amenorrhoeic for the last 24 months) not using effective means of contraception * Non-affiliation to the sécurité sociale
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Steroid dosage required to control brain edema on the last day of radiotherapy in each arm | Up to Day 42+ 1 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life (EORTC) | Day-10 at -7, Day 42, Day 42+1 month | — |
| Progression free survival | up to 24 months | — |
| Overall survival | up to 24 months | — |
| Survival | at 1 year, 2 year | — |
| Steroids dosage 1 month after the end of RT | Day 42+ 1 month | — |
| Assessment of cerebral edema on MRI | Day -28 at -13, Day 42, Day 42+1 month | — |
| Executive functions ( Moca test ) | Day-10 at -7, Day 42, Day 42+1 month | — |
| Blood pressure | Day -10 at -7, Day0, 42, Day 42+1month | — |
| HbA1C | Day -10 at -7, D42, Day 42+1month | — |
| glycemia | Day -10 at -7, Day14, 28, 42, Day 42+1month | — |
| body weight | Day -10 at -7, Day42, Day 42+1month | — |
| side-effects of steroids | up to day42 +1 month | — |
| Performance status (KPS) at the end, 1 month , and 2 months after the end of RT | at the end, 1 month, and 2 months after the end of RT | — |
| Tolerance (NCI-CTCAE v3.0) | up to day42 +1 month + 7 days | To be reported according to NCI/CTC version 3.0 (adverse events) |
Countries
France
Outcome results
None listed