Overview

This trial is active, not recruiting.

Condition newly-diagnosed glioblastoma
Treatments losartan, placebo
Phase phase 3
Sponsor Assistance Publique - Hôpitaux de Paris
Collaborator ANOCEF (french association of neuro-oncologists)
Start date March 2013
End date December 2014
Trial size 80 participants
Trial identifier NCT01805453, 2012-004536-34, P120105

Summary

To assess the efficacy of an Angiotensin-II inhibitor (Losartan) to reduce peritumoral edema in newly diagnosed glioblastoma patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
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
losartan
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
(Placebo Comparator)
Arm B: Standard of care (Radiotherapy with concomitant temozolomide followed by monthly cures of temozolomide + Placebo 2/day until the halting for any reason
placebo
Standard of care (Radiotherapy with concomitant temozolomide followed by monthly cures of temozolomide + Placebo 2/day until the halting for any reason

Primary Outcomes

Measure
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

Measure
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)
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
Progression free survival
time frame: up to 24 months
Overall survival
time frame: up to 24 months
Survival
time frame: at 1 year, 2 year
Performance status (KPS) at the end, 1 month , and 2 months after the end of RT
time frame: at the end, 1 month, and 2 months after the end of RT

Eligibility Criteria

Male or female participants at least 18 years old.

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"

Additional Information

Official title Angiotensin II Receptor Blockers, Steroids and Radiotherapy in Glioblastoma- A Randomized Multicenter Trial
Principal investigator Antoine CARPENTIER, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.