Title
Angiotensin II Receptor Blockers, Steroids and Radiotherapy in Glioblastoma
Angiotensin II Receptor Blockers, Steroids and Radiotherapy in Glioblastoma- A Randomized Multicenter Trial
Phase
Phase 3Lead Sponsor
University of ParisStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Newly-diagnosed GlioblastomaIntervention/Treatment
losartan ...Study Participants
80To assess the efficacy of an Angiotensin-II inhibitor (Losartan) to reduce peritumoral edema in newly diagnosed glioblastoma patients.
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.
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
Standard of care (Radiotherapy with concomitant temozolomide followed by monthly cures of temozolomide + Placebo 2/day until the halting for any reason
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
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"
