Angiotensin II Receptor Blockers, Steroids and Radiotherapy in Glioblastoma

Newly-diagnosed Glioblastoma Clinical Trial

— ASTER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01805453
• Other study ID #: P120105
• Secondary ID: 2012-004536-34
• Status: Completed
• Phase: Phase 3
• Start date: March 29, 2013
• Est. completion date: May 15, 2017

Study information

• Verified date: May 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 15, 2017
• Est. primary completion date: January 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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"

Related Conditions & MeSH terms

• Glioblastoma
• Newly-diagnosed Glioblastoma

Intervention

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

Locations

Country	Name	City	State
France	Neurology Department - Avicenne Hospital	Bobigny

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	ANOCEF (french association of neuro-oncologists)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Steroid dosage required to control brain edema on the last day of radiotherapy in each arm		Up to Day 42+ 1 month
Secondary	Steroids dosage 1 month after the end of RT		Day 42+ 1 month
Secondary	Assessment of cerebral edema on MRI		Day -28 at -13, Day 42, Day 42+1 month
Secondary	Tolerance (NCI-CTCAE v3.0)	To be reported according to NCI/CTC version 3.0 (adverse events)	up to day42 +1 month + 7 days
Secondary	Blood pressure		Day -10 at -7, Day0, 42, Day 42+1month
Secondary	HbA1C		Day -10 at -7, D42, Day 42+1month
Secondary	glycemia		Day -10 at -7, Day14, 28, 42, Day 42+1month
Secondary	body weight		Day -10 at -7, Day42, Day 42+1month
Secondary	side-effects of steroids		up to day42 +1 month
Secondary	Executive functions ( " Moca test ")		Day-10 at -7, Day 42, Day 42+1 month
Secondary	Quality of life (EORTC)		Day-10 at -7, Day 42, Day 42+1 month
Secondary	Progression free survival		up to 24 months
Secondary	Overall survival		up to 24 months
Secondary	Survival		at 1 year, 2 year
Secondary	Performance status (KPS) at the end, 1 month , and 2 months after the end of RT		at the end, 1 month, and 2 months after the end of RT