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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004536-34 | EudraCT Number |
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| Name | Class |
|---|---|
| ANOCEF (french association of neuro-oncologists) | UNKNOWN |
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To assess the efficacy of an Angiotensin-II inhibitor (Losartan) to reduce peritumoral edema in newly diagnosed glioblastoma patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Losartan | Active Comparator | 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: Placebo | Placebo Comparator | Arm B: Standard of care (Radiotherapy with concomitant temozolomide followed by monthly cures of temozolomide + Placebo 2/day until the halting for any reason |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Losartan | Drug | Standard of care (Radiotherapy with concomitant temozolomide followed by monthly cures of temozolomide ) + Losartan or placebo (Arm A or B) 50mg*2/day until the halting for any reason |
| Measure | Description | Time Frame |
|---|---|---|
| Steroid dosage required to control brain edema on the last day of radiotherapy in each arm | Up to Day 42+ 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Steroids dosage 1 month after the end of RT | Day 42+ 1 month | |
| Assessment of cerebral edema on MRI | Day -28 at -13, Day 42, Day 42+1 month | |
| Tolerance (NCI-CTCAE v3.0) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antoine CARPENTIER, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurology Department - Avicenne Hospital | Bobigny | 93000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30716716 | Derived | Ursu 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. |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D004487 | Edema |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| D019808 | Losartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Placebo | Drug | Standard of care (Radiotherapy with concomitant temozolomide followed by monthly cures of temozolomide + Placebo 2/day until the halting for any reason |
|
To be reported according to NCI/CTC version 3.0 (adverse events) |
| up to day42 +1 month + 7 days |
| Blood pressure | Day -10 at -7, Day0, 42, Day 42+1month |
| HbA1C | Day -10 at -7, D42, Day 42+1month |
| glycemia | Day -10 at -7, Day14, 28, 42, Day 42+1month |
| body weight | Day -10 at -7, Day42, Day 42+1month |
| side-effects of steroids | up to day42 +1 month |
| Executive functions ( " Moca test ") | Day-10 at -7, Day 42, Day 42+1 month |
| Quality of life (EORTC) | Day-10 at -7, Day 42, Day 42+1 month |
| Progression free survival | up to 24 months |
| Overall survival | up to 24 months |
| Survival | at 1 year, 2 year |
| Performance status (KPS) at the end, 1 month , and 2 months after the end of RT | at the end, 1 month, and 2 months after the end of RT |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |