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Recruiting NCT03144167

Study of Prognostic Biomarkers of Survival at 6 Months for Patients Treated With Bevacizumab Glioblastomas in First Relapse After Failure of Radiochemotherapy

Trial Parameters

Condition Glioblastoma
Sponsor Centre Hospitalier Universitaire, Amiens
Study Type INTERVENTIONAL
Phase N/A
Enrollment 170
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2019-06-18
Completion 2027-01-20
Interventions
Analysis of spectroscopic biomarkers of proliferation for six-month survival

Brief Summary

No predictive factors are known for the response to the bevacizumab anti-angiogenic molecule (Avastin) given in the event of relapse of glioblastoma (GBM) following radiochemotherapy. Classical MRI with gadolinium injection and perfusion is not sufficient to predict survival and response or duration. We propose to evaluate the prognostic interest for 6-month survival of spectroscopic biomarkers of proliferation, glial reaction, infiltration and glutaminergic metabolism or glycolytic metabolism recorded at 7 and 28 days of application of the treatment. These biomarkers are based on the increase of an index combining choline / Creatine (Cho / Cr), Glx / Cr (Glutamine and glutamate / Creatine), NAA / Cr (N acetyl aspartate / Creatine) and lactate / Cr ratios. The long-term objective is to predict the survival of these relapsed GBM patients at an early stage and to identify responder patients who would benefit from this expensive molecule and avoid using it in non-responding patients

Eligibility Criteria

Inclusion Criteria: * Patients, between 18 and 88 years, with glioblastoma (histologically proven) in first relapse after conventional treatment by surgery and temozolomide and radiotherapy * Biological Criteria * Polymorphonuclear neutrophils\> 1500 / mm3 * Plates\> 100,000 / mm3 * SGOT-SGPT \<5 at the upper limit of normal (ULN) * Bilirubin \<1.5 x ULN * Creatinine \<1.5 LSN and creatinine clearance * Proteinuria \<1 g / 24 hours * Patient with health insurance * Consent signed by the patient if he is lucid, or failing that by the person of trust Exclusion Criteria: * Patients who can not benefit from bevacizumab for the following reasons: * Symptomatic cerebral or tumor hemorrhage * Karnofsky Index less than 50% or * Patients already treated with an antiangiogenic molecule or Gliadel (diagnosis and recurrence). * Coagulation disorders in case of injectable treatment (especially for avastin), * Contraindications known to the MRI: Pace Makers, foreign bodies intraocular, electrodes ..

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