Trial record 1 of 2 for:
losartan | glioblastoma
Angiotensin II Receptor Blockers, Steroids and Radiotherapy in Glioblastoma (ASTER)
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| ClinicalTrials.gov Identifier: NCT01805453 |
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Recruitment Status : Unknown
Verified February 2017 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was: Active, not recruiting
First Posted : March 6, 2013
Last Update Posted : March 1, 2017
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Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborator:
ANOCEF (french association of neuro-oncologists)
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
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Brief Summary:
To assess the efficacy of an Angiotensin-II inhibitor (Losartan) to reduce peritumoral edema in newly diagnosed glioblastoma patients.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Newly-diagnosed Glioblastoma | Drug: Losartan Drug: Placebo | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated 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 |
| Estimated Study Completion Date : | May 15, 2017 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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 |
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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 |
Primary Outcome Measures :
- Steroid dosage required to control brain edema on the last day of radiotherapy in each arm [ Time Frame: Up to Day 42+ 1 month ]
Secondary Outcome Measures :
- 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 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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"
Information from the National Library of Medicine
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
Locations
| France | |
| Neurology Department - Avicenne Hospital | |
| Bobigny, France, 93000 | |
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
ANOCEF (french association of neuro-oncologists)
Investigators
| Principal Investigator: | Antoine CARPENTIER, MD, PhD | Assistance Publique - Hôpitaux de Paris |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT01805453 History of Changes |
| Other Study ID Numbers: |
P120105 2012-004536-34 ( EudraCT Number ) |
| First Posted: | March 6, 2013 Key Record Dates |
| Last Update Posted: | March 1, 2017 |
| Last Verified: | February 2017 |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
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Glioblastoma Angiotensin-II inhibitors Losartan steroids |
Radiotherapy Edema Randomized trial |
Additional relevant MeSH terms:
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Glioblastoma Losartan Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Temozolomide Angiotensin II Giapreza |
Angiotensin Receptor Antagonists Angiotensinogen Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Anti-Arrhythmia Agents Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Vasoconstrictor Agents Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors |