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

20 oktober 2015 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

182

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 1
Geneesmiddel: bevacizumab [Avastin]
10mg/kg iv every 2 weeks
Geneesmiddel: irinotecan
125mg/m2 iv every 2 weeks
Actieve vergelijker: 2
Geneesmiddel: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 Months
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression-Free Survival (PFS)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: From baseline until end of study (up to 4.5 years)
From baseline until end of study (up to 4.5 years)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hoffmann-La Roche

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juni 2010

Primaire voltooiing (Werkelijk)

1 september 2014

Studie voltooiing (Werkelijk)

1 september 2014

Studieregistratiedata

Eerst ingediend

16 juni 2009

Eerst ingediend dat voldeed aan de QC-criteria

26 augustus 2009

Eerst geplaatst (Schatting)

27 augustus 2009

Updates van studierecords

Laatste update geplaatst (Schatting)

20 november 2015

Laatste update ingediend die voldeed aan QC-criteria

20 oktober 2015

Laatst geverifieerd

1 oktober 2015

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ML21965
  • 2009-010390-21

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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