NCT01805453

Brief Summary

To assess the efficacy of an Angiotensin-II inhibitor (Losartan) to reduce peritumoral edema in newly diagnosed glioblastoma patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2013

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 6, 2013

Completed
23 days until next milestone

Study Start

First participant enrolled

March 29, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2015

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2017

Completed
Last Updated

May 8, 2020

Status Verified

May 1, 2020

Enrollment Period

1.8 years

First QC Date

February 25, 2013

Last Update Submit

May 7, 2020

Conditions

Newly-diagnosed Glioblastoma

Keywords

GlioblastomaAngiotensin-II inhibitorsLosartansteroidsRadiotherapyEdemaRandomized trial

Outcome Measures

Primary Outcomes (1)

  • Steroid dosage required to control brain edema on the last day of radiotherapy in each arm

    Up to Day 42+ 1 month

Secondary Outcomes (14)

  • Steroids dosage 1 month after the end of RT

    Day 42+ 1 month

  • Assessment of cerebral edema on MRI

    Day -28 at -13, Day 42, Day 42+1 month

  • Tolerance (NCI-CTCAE v3.0)

    up to day42 +1 month + 7 days

  • Blood pressure

    Day -10 at -7, Day0, 42, Day 42+1month

  • HbA1C

    Day -10 at -7, D42, Day 42+1month

  • +9 more secondary outcomes

Study Arms (2)

Arm A: Losartan

ACTIVE COMPARATOR

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

Arm B: Placebo

PLACEBO COMPARATOR

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

Interventions

LosartanDRUG

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

Arm A: Losartan
PlaceboDRUG

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

Arm B: Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Histologically confirmed glioblastoma (Grade 4 WHO)
  • patients eligible for radiotherapy and concomitant Temozolomide
  • KPS ≥ 50%
  • Adequate hematologic, liver and renal functions

You may not qualify if:

  • 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
  • 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"

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurology Department - Avicenne Hospital

Bobigny, 93000, France

Location

Related Publications (1)

  • 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.

    PMID: 30716716DERIVED

MeSH Terms

Conditions

GlioblastomaEdema

Interventions

Losartan

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazoles

Study Officials

  • Antoine CARPENTIER, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2013

First Posted

March 6, 2013

Study Start

March 29, 2013

Primary Completion

January 15, 2015

Study Completion

May 15, 2017

Last Updated

May 8, 2020

Record last verified: 2020-05

Locations

FR(1)