CompletedNot Applicable

Upfront Bevacizumab/témozolomide for Gliomastomas With Neurological Impairment

France70 participantsStarted 2011-01-01

Plain-language summary

New approaches are needed for patients newly diagnosed with bulky glioblastoma (GB) and/or with severe neurological impairment that cannot benefit from first line temozolomide (TMZ)-basedn chemoradiotherapy. Bevacizumab (BEV), an antiangiogenic anti-VEGF-R monoclonal antibody, has a rapid impact on tumor-related brain edema in recurrent GB. The present study reports the feasibility and efficacy of an induction treatment with TMZ and BEV to alleviate the initial neurological impairment and/or to reduce the tumor volume before a delayed chemoradiotherapy.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Clinical criteria:- - age\> to 18 years * GBM de novo * Histological evidence is essential. A minimum interval of 7 days is required between biopsy and neo-adjuvant therapy. A minimum interval of 15 days is required for open skull surgery and neo-adjuvant therapy. * The insertion of patients is a WHO score 3 and 4 in relation to the neurological deficit is possible by definition * Biological criteria \- Polynuclear neutrophils\> 1500 / mm3 * pads\> 100,000 / mm3 * SGOT \<5 at the upper limit of normal (ULN) * bilirubin \<1.5 x ULN * Creatinine \<1.5 ULN * proteinuria \<2 g / 24 hours * Forensic criteria * Patient with health insurance * consent signed by the patient if it is lucid, or by default by the person of trust. Exclusion Criteria: * 1\. Patients without neurological deficit (SN 0) or with moderate deficit (SN 1 or SN 2). 2\. In case of initial neurological deficit SN 3-4, the interest of a decompression surgery must be discussed. If the surgery is unsuccessful, a corticosteroid test, at least 4 days, with at least 1.5 mg / kg / day of prednisone equivalent, must be performed. If surgery and / or corticosteroids allow to return to an SN 0-2 neurological score with return to an RPA III, IV or V class, the patient is not included and must be treated according to a conventional chemoradiotherapy regimen with temozolomide (Stupp schema). 3\. Multifocal tumor or whose excessive volume does not allow to consider curativ…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial used bevacizumab and temozolomide upfront before chemoradiotherapy for glioblastoma patients with neurological impairment — does my specific situation, including my neurological symptoms, match the kind of patients who were enrolled in this study?
2Since this trial is now completed, has the data been published or presented anywhere, and what did it find about whether starting with bevacizumab and temozolomide before standard chemoradiotherapy actually helped patients like me?
3The trial was focused on patients who already had neurological impairment — does that mean the upfront drug approach was being tested as a way to stabilize patients before they could tolerate full chemoradiotherapy, and would that reasoning apply to my condition?
4This study has no listed phase, which can mean it was exploratory or observational — does that affect how much we can rely on its findings compared to a larger Phase 3 trial, and should that influence whether we consider this approach for me?
5Are there currently standard treatment options for my situation that have stronger evidence behind them, and how does what this trial found compare to those when thinking about next steps for my care?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Optimal chemoradiotherapy after upfront TMZ and BEV treatment.

Timeframe: 4-months

Trial details

NCT IDNCT03623347

SponsorCentre Hospitalier Universitaire, Amiens

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-05-12

View on ClinicalTrials.gov More Chemoradiotherapy trials