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A Study of Avastin (Bevacizumab) and Irinotecan Versus Temozolomide Radiochemistry in Patients With Glioblastoma

20 octobre 2015 mis à jour par: Hoffmann-La Roche
This 2 arm study will compare the effect of Avastin + irinotecan versus temozolomide, in combination with conventional involved field radiotherapy, in patients with newly diagnosed glioblastoma and a non-methylated MGMT promoter. Patients will be randomized 3:1 to receive Avastin 10mg/kg iv every 2 weeks + irinotecan 125mg/m2 iv every 2 weeks, or temozolomide 75mg/m2 po daily during radiotherapy followed by 6 cycles of temozolomide 150-200mg/m2 po daily on days 1-5 of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

182

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Allemagne
      • Aachen, Allemagne, 52074
      • Berlin, Allemagne, 13353
      • Bochum, Allemagne, 44892
      • Bonn, Allemagne, 53127
      • Chemnitz, Allemagne, 09113
      • Dresden, Allemagne, 01307
      • Düsseldorf, Allemagne, 40225
      • Erfurt, Allemagne, 99089
      • Erlangen, Allemagne, 91054
      • Frankfurt am Main, Allemagne, 60528
      • Freiburg, Allemagne, 79106
      • Göttingen, Allemagne, 37075
      • Idar-Oberstein, Allemagne, 55743
      • Kiel, Allemagne, 24105
      • Köln, Allemagne, 50937
      • Leipzig, Allemagne, 04103
      • Mannheim, Allemagne, 68167
      • Marburg, Allemagne, 35043
      • Muenchen, Allemagne, 81377
      • München, Allemagne, 81675
      • Münster, Allemagne, 48149
      • Regensburg, Allemagne, 93053
      • Tübingen, Allemagne, 72076
      • Ulm, Allemagne, 89081

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 70 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • adult patients, 18-70 years of age;
  • glioblastoma, confirmed histologically;
  • no previous chemotherapy or radiotherapy for glioblastoma;
  • non-methylated MGMT promoter in the tumor.

Exclusion Criteria:

  • prior systemic treatment for glioblastoma multiforme;
  • prior treatment with Avastin;
  • significant cardiovascular disease;
  • other active malignant disease.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 1
Médicament: bevacizumab [Avastin]
10mg/kg iv every 2 weeks
Médicament: irinotecan
125mg/m2 iv every 2 weeks
Comparateur actif: 2
Médicament: temozolomide
75mg/m2 po daily during radiotherapy, followed by 150-200mg/m2/day po on days 1-5 of each 6x4 week cycle of adjuvant therapy

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 Months
Délai: 6 months
Progression-free survival was defined as the time from randomization to objective tumor progression or death from any cause, whichever came first. Progression was defined as 25 percent (%) increase in size of enhancing tumor or any new tumor on gadolinium contrast agent magnetic resonance imaging (Gd-MRI) scans, or neurologically worse, and steroids stable or increased. Percentage of participants achieving PFS without disease progression or death was reported.
6 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Progression-Free Survival (PFS)
Délai: From baseline to the end of the study (up to 4.5 years)
Progression-free survival was defined as the time from randomization to objective tumor progression or death from any cause, whichever came first. Progression was defined as 25% increase in size of enhancing tumor or any new tumor on Gd-MRI scans, or neurologically worse, and steroids stable or increased. PFS was estimated using Kaplan-Meier method.
From baseline to the end of the study (up to 4.5 years)
Overall Survival (OS)
Délai: From baseline until death (up to 4.5 years)
Overall survival was defined as the time from randomization to death from any cause. OS was estimated using Kaplan-Meier method.
From baseline until death (up to 4.5 years)
Percentage of Participants Who Discontinued
Délai: From baseline until death (up to 4.5 years)
Discontinuation was defined as the percentage of participants who permanently discontinued treatment in either treatment arm. Percentage of participant with individual discontinuation reason are reported. CNS: central nervous system; CTCAE: Common Terminology Criteria for Adverse Events . Other reason refers to any other reason than the specified ones.
From baseline until death (up to 4.5 years)
Number of Participants With A Best Overall Response (BOR) of Complete Response (CR) and With A BOR of CR or Partial Response (PR)
Délai: 4 week after radiotherapy (RT) (up to Week 4), >4 Week after RT (up to Week 8) and Month 6
BOR was defined as the best response observed for a participant during assessment. Number of participants who had BOR as CR and number of participants who had BOR as CR or PR were reported. Complete response was defined as disappearance of all enhancing tumor on consecutive Gd-MRI scans at least 1 month apart, off steroids, and neurologically stable or improved. Partial response was defined as 50% reduction in size of enhancing tumor on consecutive Gd-MRI scans at least 1 month apart, steroids stable or reduced, and neurologically stable or improved.
4 week after radiotherapy (RT) (up to Week 4), >4 Week after RT (up to Week 8) and Month 6
Percentage of Participants With Response on FLAIR Imaging
Délai: At screening, Baseline, Month 6 and Therapy Discontinuation (Up to 4.5 years)

FLAIR lesions were determined as "stable", "progressive" or "decreased". FLAIR lesions was determined as "progressive" only if they were not be attributed to causes apart from tumor infiltration (sequelae of radiation therapy, demyelination, ischemia, infection, seizures, or other treatment effects). Percentage of participants are based on ITT population.

Dis.=Discontinuation.
At screening, Baseline, Month 6 and Therapy Discontinuation (Up to 4.5 years)
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ - C30) at Baseline, Post-Baseline (up to Month 30)
Délai: Baseline, Post-Baseline (up to Month 30)
The EORTC QLQ-C30 incorporates: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties); and a global health and quality-of-life scale. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores were averaged and transformed to 0-100 scale; higher score for Global Qol/functional scales=better level of functioning or a higher score for symptom scale=greater degree of symptoms. The change in global health status was determined to be the difference in values at baseline and each specific visit. The term ''baseline'' refers to the time of randomization to the maintenance phase.
Baseline, Post-Baseline (up to Month 30)
Change From Baseline for EORTC QLQ Brain Neoplasm 20 (BN20) at Baseline, Post-Baseline (up to Month 30)
Délai: Baseline, Post-Baseline (up to Month 30)
EORTC QLQ-BN20 consisted of 20 items assessing visual disorders, motor dysfunction, communication deficit, various disease symptoms (e.g. headaches and seizures), treatment toxicities (e.g. hair loss) and future uncertainty. All of the 20 items are rated on a 4 point Likert scale from 1=not at all, 2=a little, 3=quite a bit and 4=very much, and were linearly transformed to a 0-100 scale, with higher scores indicating more severe symptoms.
Baseline, Post-Baseline (up to Month 30)
Change From Baseline for Mini-Mental Status Examination (MMSE) at Baseline, Post-Baseline (up to Month 30)
Délai: Baseline, Post-Baseline (up to Month 30)
The MMSE briefly measures orientation to time and place, immediate recall, short-term verbal memory, calculation, language and construct ability. Each area tested had a designated point value, the total score can range from 0 to 30, with a higher score indicating better function.
Baseline, Post-Baseline (up to Month 30)
Change From Baseline for Karnofsky Performance Status (KPS) Score at Baseline, Post-Baseline (up to Month 30)
Délai: Baseline, Post-Baseline (up to Month 30)
KPS is an 11-level score (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100) which ranges between 0 (death) to 100 (complete healthy status); a higher score represents a higher ability to perform daily tasks. Deterioration in KPS was defined as decrease of 20 or more points in KPS score.
Baseline, Post-Baseline (up to Month 30)
Percentage of Participants Who Received Corticosteroid for Glioblastoma
Délai: From baseline to Month 6
Participants used corticosteroids for the glioblastoma condition. Corticosteroids included dexamethasone, methylprednisone, fortecortin, hydrocortisone, urbason, and prednisolone.
From baseline to Month 6
Time to Treatment Failure
Délai: From baseline until end of study (up to 4.5 years)
From baseline until end of study (up to 4.5 years)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hoffmann-La Roche

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 juin 2010

Achèvement primaire (Réel)

1 septembre 2014

Achèvement de l'étude (Réel)

1 septembre 2014

Dates d'inscription aux études

Première soumission

16 juin 2009

Première soumission répondant aux critères de contrôle qualité

26 août 2009

Première publication (Estimation)

27 août 2009

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

20 novembre 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

20 octobre 2015

Dernière vérification

1 octobre 2015

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • ML21965
  • 2009-010390-21

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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