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Angiotensin II Receptor Blockers, Steroids and Radiotherapy in Glioblastoma (ASTER)

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ClinicalTrials.gov Identifier: NCT01805453
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
Sponsor:
Collaborator:
ANOCEF (french association of neuro-oncologists)
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

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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


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




Primary Outcome Measures :
  1. 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 :
  1. Steroids dosage 1 month after the end of RT [ Time Frame: Day 42+ 1 month ]
  2. Assessment of cerebral edema on MRI [ Time Frame: Day -28 at -13, Day 42, Day 42+1 month ]
  3. 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)

  4. Blood pressure [ Time Frame: Day -10 at -7, Day0, 42, Day 42+1month ]
  5. HbA1C [ Time Frame: Day -10 at -7, D42, Day 42+1month ]
  6. glycemia [ Time Frame: Day -10 at -7, Day14, 28, 42, Day 42+1month ]
  7. body weight [ Time Frame: Day -10 at -7, Day42, Day 42+1month ]
  8. side-effects of steroids [ Time Frame: up to day42 +1 month ]
  9. Executive functions ( " Moca test ") [ Time Frame: Day-10 at -7, Day 42, Day 42+1 month ]
  10. Quality of life (EORTC) [ Time Frame: Day-10 at -7, Day 42, Day 42+1 month ]
  11. Progression free survival [ Time Frame: up to 24 months ]
  12. Overall survival [ Time Frame: up to 24 months ]
  13. Survival [ Time Frame: at 1 year, 2 year ]
  14. 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
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
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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:
Glioblastoma
Angiotensin-II inhibitors
Losartan
steroids
Radiotherapy
Edema
Randomized trial

Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Losartan
Angiotensin Receptor Antagonists
Angiotensin II
Giapreza
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