Angiotensin II Receptor Blockers, Steroids and Radiotherapy in Glioblastoma
- Registration Number
- NCT01805453
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
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"
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B: Placebo Placebo Arm B: Standard of care (Radiotherapy with concomitant temozolomide followed by monthly cures of temozolomide + Placebo 2/day until the halting for any reason Arm A: Losartan Losartan 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
- Primary Outcome Measures
Name Time Method Steroid dosage required to control brain edema on the last day of radiotherapy in each arm Up to Day 42+ 1 month
- Secondary Outcome Measures
Name Time Method Progression free survival up to 24 months Steroids dosage 1 month after the end of RT Day 42+ 1 month side-effects of steroids up to day42 +1 month Quality of life (EORTC) Day-10 at -7, Day 42, Day 42+1 month Overall survival up to 24 months Tolerance (NCI-CTCAE v3.0) up to day42 +1 month + 7 days To be reported according to NCI/CTC version 3.0 (adverse events)
HbA1C Day -10 at -7, D42, Day 42+1month Survival at 1 year, 2 year Assessment of cerebral edema on MRI Day -28 at -13, Day 42, Day 42+1 month Blood pressure Day -10 at -7, Day0, 42, Day 42+1month glycemia Day -10 at -7, Day14, 28, 42, Day 42+1month body weight Day -10 at -7, Day42, Day 42+1month Executive functions ( " Moca test ") Day-10 at -7, Day 42, Day 42+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
Trial Locations
- Locations (1)
Neurology Department - Avicenne Hospital
🇫🇷Bobigny, France