Overview

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"