Angiotensin II Receptor Blockers, Steroids and Radiotherapy in Glioblastoma

Assistance Publique - Hôpitaux de Paris80 enrolled

Overview

To 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Newly-diagnosed Glioblastoma

Interventions

LosartanDRUG

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

PlaceboDRUG

Standard of care (Radiotherapy with concomitant temozolomide followed by monthly cures of temozolomide + Placebo 2/day until the halting for any reason

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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"

Locations (1)

Neurology Department - Avicenne Hospital

Bobigny, France

Outcomes

Primary Outcomes

Steroid dosage required to control brain edema on the last day of radiotherapy in each arm

Time frame: Up to Day 42+ 1 month

Secondary Outcomes

Steroids dosage 1 month after the end of RT

Time frame: Day 42+ 1 month

Assessment of cerebral edema on MRI

Time frame: Day -28 at -13, Day 42, Day 42+1 month

Tolerance (NCI-CTCAE v3.0)

To be reported according to NCI/CTC version 3.0 (adverse events)

Time frame: up to day42 +1 month + 7 days

Blood pressure

Time frame: Day -10 at -7, Day0, 42, Day 42+1month

HbA1C

Time frame: Day -10 at -7, D42, Day 42+1month

glycemia

Time frame: Day -10 at -7, Day14, 28, 42, Day 42+1month

body weight

Time frame: Day -10 at -7, Day42, Day 42+1month

side-effects of steroids

Time frame: up to day42 +1 month

Executive functions ( " Moca test ")

Time frame: Day-10 at -7, Day 42, Day 42+1 month

Quality of life (EORTC)

Time frame: Day-10 at -7, Day 42, Day 42+1 month

Data from ClinicalTrials.gov

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