Newly-diagnosed GlioblastomaPhase 3ASTERNCT01805453
Angiotensin II Receptor Blockers, Steroids and Radiotherapy in Glioblastoma
A Phase 3 study testing Losartan in people with Newly-diagnosed Glioblastoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
To assess the efficacy of an Angiotensin-II inhibitor (Losartan) to reduce peritumoral edema in newly diagnosed glioblastoma patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Newly-diagnosed Glioblastoma
- What is being tested?
- Losartan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 29 Mar 2013to 15 May 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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"
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Angiotensin II Receptor Blockers, Steroids and Radiotherapy in Glioblastoma- A Randomized Multicenter Trial
To assess the efficacy of an Angiotensin-II inhibitor (Losartan) to reduce peritumoral edema in newly diagnosed glioblastoma patients.
Read the 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.
- Conditions
- Newly-diagnosed Glioblastoma
- Being tested
- Losartan, Placebo
- Keywords
- Glioblastoma, Angiotensin-II inhibitors, Losartan, steroids, Radiotherapy, Edema, Randomized trial
- Medical subject headings
- Glioblastoma, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
PlaceboDrug
Standard of care (Radiotherapy with concomitant temozolomide followed by monthly cures of temozolomide + Placebo 2/day until the halting for any reason
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steroid dosage required to control brain edema on the last day of radiotherapy in each arm
Measured: Up to Day 42+ 1 month
Secondary outcomes (14)
Steroids dosage 1 month after the end of RT
Measured: Day 42+ 1 month
Assessment of cerebral edema on MRI
Measured: Day -28 at -13, Day 42, Day 42+1 month
Tolerance (NCI-CTCAE v3.0)
To be reported according to NCI/CTC version 3.0 (adverse events)
Measured: up to day42 +1 month + 7 days
Blood pressure
Measured: Day -10 at -7, Day0, 42, Day 42+1month
HbA1C
Measured: Day -10 at -7, D42, Day 42+1month
glycemia
Measured: Day -10 at -7, Day14, 28, 42, Day 42+1month
body weight
Measured: Day -10 at -7, Day42, Day 42+1month
side-effects of steroids
Measured: up to day42 +1 month
Executive functions ( " Moca test ")
Measured: Day-10 at -7, Day 42, Day 42+1 month
Quality of life (EORTC)
Measured: Day-10 at -7, Day 42, Day 42+1 month
Progression free survival
Measured: up to 24 months
Overall survival
Measured: up to 24 months
Survival
Measured: at 1 year, 2 year
Performance status (KPS) at the end, 1 month , and 2 months after the end of RT
Measured: at the end, 1 month, and 2 months after the end of RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2013 (estimated)
- Study start29 Mar 2013
- Primary completion15 Jan 2015
- Study completion15 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Newly-diagnosed GlioblastomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- ANOCEF (french association of neuro-oncologists)
- Responsible party
- Sponsor
- Investigators
- Antoine CARPENTIER, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805453
- Sponsor's protocol ID
- P120105
- Other IDs
- 2012-004536-34
- Acronym
- ASTER
- Status last verified
- May 2020
- First submitted
- 25 Feb 2013
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 30716716
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angiotensin II Receptor Blockers, Steroids and Radiotherapy in Glioblastoma- A Randomized Multicenter Trial
- ClinicalTrials.gov ID
- NCT01805453
- Acronym / sponsor ID
- ASTER / P120105
- Conditions
- Newly-diagnosed Glioblastoma
- Keywords
- Glioblastoma, Angiotensin-II inhibitors, Losartan, steroids, Radiotherapy, Edema, Randomized trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- ANOCEF (french association of neuro-oncologists)
- Study start
- 29 Mar 2013 (actual)
- Primary completion
- 15 Jan 2015 (actual)
- Study completion
- 15 May 2017 (actual)
- First posted
- 6 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Losartan | Active comparator | Drug: LosartanArm 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: Placebo | Placebo comparator | Drug: PlaceboArm B: Standard of care (Radiotherapy with concomitant temozolomide followed by monthly cures of temozolomide + Placebo 2/day until the halting for any reason |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LosartanStandard 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 | Arm A: Losartan |
| PlaceboStandard of care (Radiotherapy with concomitant temozolomide followed by monthly cures of temozolomide + Placebo 2/day until the halting for any reason | Drug | Arm B: Placebo |
Primary outcome
Steroid dosage required to control brain edema on the last day of radiotherapy in each arm
Time frame: Up to Day 42+ 1 month
14 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
- Derived from this study: PubMed 30716716Ursu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine CARPENTIER, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Losartan in people with Newly-diagnosed Glioblastoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steroid dosage required to control brain edema on the last day of radiotherapy in each arm (time frame: Up to Day 42+ 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01805453, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2020.