Angiotensin II Receptor Blockers, Steroids and Radiotherapy in Glioblastoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-29

Study Completion Date

2017-05-15

Brief Summary

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

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Detailed Description

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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.

Conditions

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Newly-diagnosed Glioblastoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm A: 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

Group Type ACTIVE_COMPARATOR

Losartan

Intervention Type 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

Arm B: 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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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"

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No