Angiotensin II Receptor Blockers, Steroids and Radiotherapy in Glioblastoma (ASTER)
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ClinicalTrials.gov Identifier: NCT01805453 |
Recruitment Status :
Completed
First Posted : March 6, 2013
Last Update Posted : May 8, 2020
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Condition or disease | Intervention/treatment | Phase |
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Newly-diagnosed Glioblastoma | Drug: Losartan Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Angiotensin II Receptor Blockers, Steroids and Radiotherapy in Glioblastoma- A Randomized Multicenter Trial |
Actual Study Start Date : | March 29, 2013 |
Actual Primary Completion Date : | January 15, 2015 |
Actual Study Completion Date : | May 15, 2017 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Arm A: Losartan
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
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Drug: Losartan
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 |
Placebo Comparator: Arm B: Placebo
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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Drug: Placebo
Standard of care (Radiotherapy with concomitant temozolomide followed by monthly cures of temozolomide + Placebo 2/day until the halting for any reason |
- Steroid dosage required to control brain edema on the last day of radiotherapy in each arm [ Time Frame: Up to Day 42+ 1 month ]
- Steroids dosage 1 month after the end of RT [ Time Frame: Day 42+ 1 month ]
- Assessment of cerebral edema on MRI [ Time Frame: Day -28 at -13, Day 42, Day 42+1 month ]
- Tolerance (NCI-CTCAE v3.0) [ Time Frame: up to day42 +1 month + 7 days ]To be reported according to NCI/CTC version 3.0 (adverse events)
- Blood pressure [ Time Frame: Day -10 at -7, Day0, 42, Day 42+1month ]
- HbA1C [ Time Frame: Day -10 at -7, D42, Day 42+1month ]
- glycemia [ Time Frame: Day -10 at -7, Day14, 28, 42, Day 42+1month ]
- body weight [ Time Frame: Day -10 at -7, Day42, Day 42+1month ]
- side-effects of steroids [ Time Frame: up to day42 +1 month ]
- Executive functions ( " Moca test ") [ Time Frame: Day-10 at -7, Day 42, Day 42+1 month ]
- Quality of life (EORTC) [ Time Frame: Day-10 at -7, Day 42, Day 42+1 month ]
- Progression free survival [ Time Frame: up to 24 months ]
- Overall survival [ Time Frame: up to 24 months ]
- Survival [ Time Frame: at 1 year, 2 year ]
- Performance status (KPS) at the end, 1 month , and 2 months after the end of RT [ Time Frame: at the end, 1 month, and 2 months after the end of RT ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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"

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01805453
France | |
Neurology Department - Avicenne Hospital | |
Bobigny, France, 93000 |
Principal Investigator: | Antoine CARPENTIER, MD, PhD | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT01805453 |
Other Study ID Numbers: |
P120105 2012-004536-34 ( EudraCT Number ) |
First Posted: | March 6, 2013 Key Record Dates |
Last Update Posted: | May 8, 2020 |
Last Verified: | May 2020 |
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