Angiotensin II Receptor Blockers, Steroids and Radiotherapy in Glioblastoma (ASTER)

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 3

Conditions: Newly-diagnosed Glioblastoma

Treatments: Drug: Placebo; Drug: Losartan

Study type: Interventional

Funder types: Other

Identifiers

NCT01805453

P120105

2012-004536-34 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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"

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Arm A: Losartan

Active Comparator group

Description:

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

Treatment:

Drug: Losartan

Arm B: Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo