---
title: Angiotensin II Receptor Blockers, Steroids and Radiotherapy in Glioblastoma
nct_id: NCT01805453
overall_status: COMPLETED
phase: PHASE3
sponsor: Assistance Publique - Hôpitaux de Paris
study_type: INTERVENTIONAL
primary_condition: Newly-diagnosed Glioblastoma
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01805453.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01805453"
ct_last_update_post_date: 2020-05-08
last_seen_at: "2026-05-12T06:25:22.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Angiotensin II Receptor Blockers, Steroids and Radiotherapy in Glioblastoma

**Official Title:** Angiotensin II Receptor Blockers, Steroids and Radiotherapy in Glioblastoma- A Randomized Multicenter Trial

**NCT ID:** [NCT01805453](https://clinicaltrials.gov/study/NCT01805453)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 80
- **Lead Sponsor:** Assistance Publique - Hôpitaux de Paris
- **Collaborators:** ANOCEF (french association of neuro-oncologists)
- **Conditions:** Newly-diagnosed Glioblastoma
- **Start Date:** 2013-03-29
- **Completion Date:** 2017-05-15
- **CT.gov Last Update:** 2020-05-08

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **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"
```

## Arms

- **Arm A: Losartan** (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
- **Arm B: Placebo** (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

## Interventions

- **Losartan** (DRUG) — 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** (DRUG) — Standard of care (Radiotherapy with concomitant temozolomide followed by monthly cures of temozolomide + Placebo 2/day until the halting for any reason

## 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)** _(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)_

## Locations (1)

- Neurology Department - Avicenne Hospital, Bobigny, France

## Recent Field Changes (last 30 days)

- `outcomes.primary` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.neurology department - avicenne hospital|bobigny||france` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT01805453*  
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