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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

Tracking Information
First Submitted Date  ICMJE February 25, 2013
First Posted Date  ICMJE March 6, 2013
Last Update Posted Date May 8, 2020
Actual Study Start Date  ICMJE March 29, 2013
Actual Primary Completion Date January 15, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2013)
Steroid dosage required to control brain edema on the last day of radiotherapy in each arm [ Time Frame: Up to Day 42+ 1 month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2013)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Angiotensin II Receptor Blockers, Steroids and Radiotherapy in Glioblastoma
Official Title  ICMJE Angiotensin II Receptor Blockers, Steroids and Radiotherapy in Glioblastoma- A Randomized Multicenter Trial
Brief Summary To assess the efficacy of an Angiotensin-II inhibitor (Losartan) to reduce peritumoral edema in newly diagnosed glioblastoma patients.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Newly-diagnosed Glioblastoma
Intervention  ICMJE
  • 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
  • Drug: Placebo
    Standard of care (Radiotherapy with concomitant temozolomide followed by monthly cures of temozolomide + Placebo 2/day until the halting for any reason
Study Arms  ICMJE
  • 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
    Intervention: Drug: Losartan
  • 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
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 4, 2013)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 15, 2017
Actual Primary Completion Date January 15, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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"
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01805453
Other Study ID Numbers  ICMJE P120105
2012-004536-34 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE ANOCEF (french association of neuro-oncologists)
Investigators  ICMJE
Principal Investigator: Antoine CARPENTIER, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP