Angiotensin II Receptor Blockers, Steroids and Radiotherapy in Glioblastoma

• Status: Completed
• Trial end date: 2017-05-15
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: ANOCEF (french association of neuro-oncologists)
• Treatments: Angiotensin II; Angiotensin Receptor Antagonists; Angiotensinogen; Losartan; Temozolomide

Criteria

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"