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Completed

NCT Number: NCT01805453

Angiotensin II Receptor Blockers, Steroids and Radiotherapy in Glioblastoma

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

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Key information

Conditions

Newly-diagnosed Glioblastoma Astrocytoma Edema Glioblastoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Neurology Department - Avicenne Hospital

Bobigny, 93000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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"

Treatment and study plan

Losartan

Drug

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

Drug

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

Primary outcomes

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

    Time frame: Up to Day 42+ 1 month

Secondary outcomes

  1. Steroids dosage 1 month after the end of RT

    Time frame: Day 42+ 1 month

  2. Assessment of cerebral edema on MRI

    Time frame: Day -28 at -13, Day 42, Day 42+1 month

  3. 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)

  4. Blood pressure

    Time frame: Day -10 at -7, Day0, 42, Day 42+1month

  5. HbA1C

    Time frame: Day -10 at -7, D42, Day 42+1month

  6. glycemia

    Time frame: Day -10 at -7, Day14, 28, 42, Day 42+1month

  7. body weight

    Time frame: Day -10 at -7, Day42, Day 42+1month

  8. side-effects of steroids

    Time frame: up to day42 +1 month

  9. Executive functions ( " Moca test ")

    Time frame: Day-10 at -7, Day 42, Day 42+1 month

  10. Quality of life (EORTC)

    Time frame: Day-10 at -7, Day 42, Day 42+1 month

  11. Progression free survival

    Time frame: up to 24 months

  12. Overall survival

    Time frame: up to 24 months

  13. Survival

    Time frame: at 1 year, 2 year

  14. 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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • ANOCEF (french association of neuro-oncologists)

Registry information

Official study title

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

Acronym: ASTER

Important dates

Study start
2013
Primary completion
2015
Study completion
2017
First posted
Mar 6, 2013
Registry last updated
May 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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