Upfront Bevacizumab/témozolomide for Gliomastomas With Neurological Impairment

NCT03623347 | Completed

• 1 other identifier: PI2011_843_0001
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chemoradiotherapy

Keywords

bully glioblastoma; multifocal glioblastoma; bevacizumab; temozolomide

Outcome Measures

Primary Outcomes (1)

• Optimal chemoradiotherapy after upfront TMZ and BEV treatment.

  The investigators reported here a series of patients in whom radiotherapy was considered as not feasible in first intention but most of which could be treated by optimal chemoradiotherapy after upfront TMZ and BEV treatment. The investigators analyzed the impact of this induction strategy on tumor and target volumes, neurological status and survival.

  4-months

Interventions

TMZ and BEV induction before chemoradiotherapy OTHER

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)-based chemoradiotherapy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• \. Patients without neurological deficit (SN 0) or with moderate deficit (SN 1 or SN 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).
• \. Multifocal tumor or whose excessive volume does not allow to consider curative radiation therapy at a dose of 60 Gy.
• \. 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.
• \. 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.
• \. Surgical procedure (other than craniotomy or stereotactic biopsy) less than one month old or foreseeable surgery.
• \. History of digestive fistula or intestinal perforation whose resolution is less than 6 months old.
• \. Pregnant or lactating patient (contraception to be prescribed if necessary) 18. Known intolerance to bevacizumab or temozolomide

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens-Picardie

Amiens, 80054, France

Location

MeSH Terms

Interventions

Temozolomide

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mathieu Boone, PH

  CHU Amiens-Picardie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 9, 2018
• Study Start: January 1, 2011
• Primary Completion: May 12, 2017
• Study Completion: May 12, 2017
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)