Clinical trial · Interventional
Angiotensin II Receptor Blockers, Steroids and Radiotherapy in Glioblastoma
Angiotensin II Receptor Blockers, Steroids and Radiotherapy in Glioblastoma- A Randomized Multicenter Trial
NCT01805453CI-TRIAL-00045014ASTERcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To assess the efficacy of an Angiotensin-II inhibitor (Losartan) to reduce peritumoral edema in newly diagnosed glioblastoma patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Newly-diagnosed Glioblastoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Losartan | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A: Losartan
- 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
- interventionNames
- Drug: Losartan
- type
- PLACEBO_COMPARATOR
- label
- Arm B: Placebo
- 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
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Steroid dosage required to control brain edema on the last day of radiotherapy in each arm
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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"
References
Publications (1)
- DERIVEDUrsu R, Thomas L, Psimaras D, Chinot O, Le Rhun E, Ricard D, Charissoux M, Cuzzubbo S, Sejalon F, Quillien V, Hoang-Xuan K, Ducray F, Portal JJ, Tibi A, Mandonnet E, Levy-Piedbois C, Vicaut E, Carpentier AF. Angiotensin II receptor blockers, steroids and radiotherapy in glioblastoma-a randomised multicentre trial (ASTER trial). An ANOCEF study. Eur J Cancer. 2019 Mar;109:129-136. doi: 10.1016/j.ejca.2018.12.025. Epub 2019 Feb 1. PMID 30716716