Status:
COMPLETED
Angiotensin II Receptor Blockers, Steroids and Radiotherapy in Glioblastoma
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
ANOCEF (french association of neuro-oncologists)
Conditions:
Newly-diagnosed Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 h...
Eligibility Criteria
Inclusion
- 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
- 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"
Key Trial Info
Start Date :
March 29 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2017
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01805453
Start Date
March 29 2013
End Date
May 15 2017
Last Update
May 8 2020
Active Locations (1)
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1
Neurology Department - Avicenne Hospital
Bobigny, France, 93000