NCT03144167Recruiting
Study of Prognostic Biomarkers of Survival at 6 Months for Patients Treated With Bevacizumab Glioblastomas in First Relapse After Failure of Radiochemotherapy
Source: ClinicalTrials.gov · Last updated 16 Jan 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 170 (estimated)
- First submitted
- 27 Apr 2017
- Start date
- 18 Jun 2019
- Primary completion date
- 20 Jan 2027
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Diseases
- Glioblastoma
- NCT number
- NCT03144167
What you commit to
- Study type: Interventional
- Planned participants: 170
- From 18 Jun 2019 to the primary completion date, 20 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients already treated with an antiangiogenic molecule or Gliadel (diagnosis and recurrence).
- Uncontrolled severe concomitant pathology, including another evolving cancer (with the exception of operative cutaneous tumors, in situ cancer of the cervix or breast treated).
- Surgical intervention (other than craniotomy or stereotactic biopsy) dating less than one month or essential and predictable surgery.
Other illness
- Patients who can not benefit from bevacizumab for the following reasons:
- Symptomatic cerebral or tumor hemorrhage
- Karnofsky Index less than 50% or
- Coagulation disorders in case of injectable treatment (especially for avastin),
- Uncontrolled Infection
- Uncontrolled hypertension (PAS\> 160 mm Hg) despite optimized treatment
- Coronary artery disease or unstable arterial disease. Evolutionary aneurysm.
- Myocardial infarction dating from less than 6 months.
- Heart Failure\> grade II NYHA
- Hemorrhagic Disease (Hemophilia, Willebrandt ...)
- Nephrotic syndrome with proteinuria\> 2 g / 24 h
- History of haemoptysis dating less than 1 month.
- History of digestive fistula or intestinal perforation with resolution less than 6 months.
- Hypersensitivity to bevacizumab or to any of the excipients mentioned in Composition.
- Hypersensitivity to Chinese hamster ovary (CHO) cells or to other human or humanized recombinant antibodies.
Other
- Contraindications known to the MRI: Pace Makers, foreign bodies intraocular, electrodes ...
- Peripheral arterial or cerebrovascular accident occurring less than 6 months.
- Pulmonary embolism dating less than 1 month.
- Severe Myelosuppression
- Pregnant or nursing. Contraception should be prescribed if necessary during treatment.
- Persons deprived of liberty or placed under safeguard of justice (guardianship or curatorship),
- Subject involved in another search including an exclusion period still in progress at pre-inclusion
- Patient refusing to participate in the study
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chu Amiens Picardie Coordinator of this site? Confirm its status | Amiens | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.