Brain tumor patients with severe symptoms may get a new treatment option
NCT ID NCT03623347
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a combination of two drugs, bevacizumab and temozolomide, given before standard chemoradiotherapy in 70 patients with newly diagnosed glioblastoma who had severe neurological symptoms. The goal was to reduce tumor size and improve symptoms enough to allow patients to receive standard treatment. The study looked at how many patients could then undergo optimal chemoradiotherapy and how their survival and quality of life were affected.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bevacizumab and temozolomide
- What this could lead to
- If this approach works, it could allow more patients with severe glioblastoma to receive life-extending chemoradiotherapy.
- What could go wrong
- This is a small, early-phase study with only 70 participants. The drugs may not shrink the tumor enough, and side effects like bleeding or high blood pressure are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
70 people
The number who actually took part.
- Started
-
Jan 2011
- Finished
-
May 2017
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The investigators retrospectively collected clinical and radiological data from medical files. Patients were over 18 years old. Most had histologically proven unresectable primary GB. in some cases, GB diagnosis was only done by multimodal MRI with confirmation by a collegial agreement including an expert in neuroradiology.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 curative radiation therapy at a dose of 60 Gy. 3\. History of chemotherapy, (including Gliadel) and / or radiotherapy. 4. Cerebral or intratumoral haemorrhage on diagnostic MRI. However, microhemorrhages, haemosiderin deposits or haemorrhages secondary to biopsy or surgery are not contraindications. 5\. Concomitant serious uncontrolled pathology, including another evolving cancer 6. Uncontrolled infection 7. Uncontrolled Hypertension (PAS\> 160 mm Hg) Despite Optimized Treatment 8. Coronary artery disease or unstable arterial disease. Evolutionary aneurysm. Myocardial infarction less than 6 months old. 9\. Stroke or peripheral arterial disease less than 6 months old. 10. Heart Failure\> NYHA Grade II 11. Haemorrhagiparous disease (hemophilia, Willebrandt ...) 12. History of hemoptysis less than 1 month old. 13. Pulmonary embolism less than 1 month old. 14. Anticoagulant or antiplatelet therapy in progress. If possible, these treatments should be stopped before inclusion after consultation with a cardiologist or angiologist. However, these treatments may be continued if their discontinuation is considered harmful and that the participation in the trial is considered beneficial for the patient with regard to the haemorrhagic risk incurred. 15\. Surgical procedure (other than craniotomy or stereotactic biopsy) less than one month old or foreseeable surgery. 16\. History of digestive fistula or intestinal perforation whose resolution is less than 6 months old. 17\. Pregnant or lactating patient (contraception to be prescribed if necessary) 18. Known intolerance to bevacizumab or temozolomide
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
CHU Amiens-Picardie
Amiens, 80054, France
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