Know Cancer

or
forgot password

Angiotensin II Receptor Blockers, Steroids and Radiotherapy in Glioblastoma- A Randomized Multicenter Trial


Phase 3
18 Years
N/A
Not Enrolling
Both
Newly-diagnosed Glioblastoma

Thank you

Trial Information

Angiotensin II Receptor Blockers, Steroids and Radiotherapy in Glioblastoma- A Randomized Multicenter Trial


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.


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 (complete surgical
resection)

- Any prior treatment of glioblastoma including any local therapy (immunotherapy,
Gliadel wafers, …..) during or after surgical resection

- Any treatment for high blood pressure, 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"

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Up to Day 42+ 1 month

Safety Issue:

Yes

Principal Investigator

Antoine CARPENTIER, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris

Authority:

France: Ministry of Health

Study ID:

P120105

NCT ID:

NCT01805453

Start Date:

March 2013

Completion Date:

May 2014

Related Keywords:

  • Newly-diagnosed Glioblastoma
  • Glioblastoma
  • Angiotensin-II inhibitors
  • Losartan
  • steroids
  • Radiotherapy
  • Edema
  • Randomized trial
  • Glioblastoma

Name

Location