Corticodependent or corticoresistant brain radionecrosis after radiotherapy for brain metastases: a multicentre randomized, controlled double-blind phase III study, comparing bevacizumab versus placebo (BRADI)

Conditions

Brain metastases of cancer > brain radionecrosis

Brief summary

- Corticosteroids dose at Cycle 1 Day 1 (C1D1) and at 3 months (90 days, End of treatment (EOT) visit) - NANO (Neurological Assessment in Neuro-Oncology) score (60) at C1D1 and at 3 months (90 days -EOT visit) The NANO scale evaluates 8 major domains of neurologic function that are most relevant to patients with supratentorial, infratentorial, and brainstem tumors

Detailed description

a) Safety assessed using the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 5.0 for up to 90 days following C1D1, b) Quality of life is measured with EORTC QLQ-C30 and BN20 (59) ; assessed at C1D1, C2D1, C3D1, C4D1 and EOT visit, c) Success assessed using: - Corticosteroid’s dose: at C1D1 and at 3 months (90 days) - NANO score: at C1D1, C2D1, C3D1, C4D1 and EOT visit - EORTC QLQC-30 and BN20 scores: at C1D1, C2D1, C3D1, C4D1 and EOT visit, d) Clinical changes assessed using: - Patient Global Impression of Change (PGIC) questionnaire (from 1 to 7) and Scale (from 0 to 10): at C4D1 and EOT visit - NANO score: at C1D1, C2D1, C3D1, C4D1 and EOT visit, e) volume on brain MRI T1 post-gadolinium and T2-weighted FLAIR: at EOT visit, f) Duration of response assessed using: - NANO scale: every 3 months until 2 years - dose of corticosteroids: every 3 months until 2 years, g) Corticosteroids dose at 3 months and vital status up to 3 months, h) Correlative biomarkers (ceramide, VEGF, angiopoietin, TGF-alpha) and nuclear medicine images

Related papers

No related papers found yet.

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGPrednisolone 10mg Tablets

DRUGSodium Chloride Fresenius Kabi Italia 0.9 % Solution for infusion

DRUGAvastin 25 mg/ml concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
- Corticosteroids dose at Cycle 1 Day 1 (C1D1) and at 3 months (90 days, End of treatment (EOT) visit) - NANO (Neurological Assessment in Neuro-Oncology) score (60) at C1D1 and at 3 months (90 days -EOT visit) The NANO scale evaluates 8 major domains of neurologic function that are most relevant to patients with supratentorial, infratentorial, and brainstem tumors	—

Secondary

Measure	Time frame
a) Safety assessed using the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 5.0 for up to 90 days following C1D1, b) Quality of life is measured with EORTC QLQ-C30 and BN20 (59) ; assessed at C1D1, C2D1, C3D1, C4D1 and EOT visit, c) Success assessed using: - Corticosteroid’s dose: at C1D1 and at 3 months (90 days) - NANO score: at C1D1, C2D1, C3D1, C4D1 and EOT visit - EORTC QLQC-30 and BN20 scores: at C1D1, C2D1, C3D1, C4D1 and EOT visit, d) Clinical changes assessed using: - Patient Global Impression of Change (PGIC) questionnaire (from 1 to 7) and Scale (from 0 to 10): at C4D1 and EOT visit - NANO score: at C1D1, C2D1, C3D1, C4D1 and EOT visit, e) volume on brain MRI T1 post-gadolinium and T2-weighted FLAIR: at EOT visit, f) Duration of response assessed using: - NANO scale: every 3 months until 2 years - dose of corticosteroids: every 3 months until 2 years, g) Corticosteroids dose at 3 months and vital status up to 3 months, h) Correl	—

Measure

Time frame

a) Safety assessed using the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 5.0 for up to 90 days following C1D1, b) Quality of life is measured with EORTC QLQ-C30 and BN20 (59) ; assessed at C1D1, C2D1, C3D1, C4D1 and EOT visit, c) Success assessed using: - Corticosteroid’s dose: at C1D1 and at 3 months (90 days) - NANO score: at C1D1, C2D1, C3D1, C4D1 and EOT visit - EORTC QLQC-30 and BN20 scores: at C1D1, C2D1, C3D1, C4D1 and EOT visit, d) Clinical changes assessed using: - Patient Global Impression of Change (PGIC) questionnaire (from 1 to 7) and Scale (from 0 to 10): at C4D1 and EOT visit - NANO score: at C1D1, C2D1, C3D1, C4D1 and EOT visit, e) volume on brain MRI T1 post-gadolinium and T2-weighted FLAIR: at EOT visit, f) Duration of response assessed using: - NANO scale: every 3 months until 2 years - dose of corticosteroids: every 3 months until 2 years, g) Corticosteroids dose at 3 months and vital status up to 3 months, h) Correl

—

Countries

France

Outcome results

None listed