Trial record 1 of 2 for: losartan | glioblastoma

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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

Sponsor:

Collaborator:

ANOCEF (french association of neuro-oncologists)

Information provided by (Responsible Party):

Assistance Publique - Hôpitaux de Paris

Study Description

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

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 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 Design

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Angiotensin II Losartan Losartan potassium

Genetic and Rare Diseases Information Center resources: Glioblastoma Glioma Neuroepithelioma

U.S. FDA Resources

Arms and Interventions

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	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	Drug: Placebo Standard of care (Radiotherapy with concomitant temozolomide followed by monthly cures of temozolomide + Placebo 2/day until the halting for any reason

Outcome Measures

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 ]

Eligibility Criteria

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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"

Contacts and Locations

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

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France
Neurology Department - Avicenne Hospital
Bobigny, France, 93000

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

ANOCEF (french association of neuro-oncologists)

Investigators

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Principal Investigator:	Antoine CARPENTIER, MD, PhD	Assistance Publique - Hôpitaux de Paris

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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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

Keywords provided by Assistance Publique - Hôpitaux de Paris:


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 Anti-Arrhythmia Agents Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action

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