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Clinical Trials/EUCTR2010-022189-28-CZ
EUCTR2010-022189-28-CZActive, not recruitingPhase 1

A PHASE II OPEN-LABEL, RANDOMIZED, MULTI- CENTRE COMPARATIVE STUDY OF BEVACIZUMAB-BASED THERAPY IN PAEDIATRIC PATIENTS WITH NEWLY DIAGNOSED SUPRATENTORIAL, INFRATENTORIAL CEREBELLAR, OR PEDUNCULAR HIGH-GRADE GLIOMA

F. Hoffmann-La Roche Ltd0 sites124 target enrollmentStarted: May 23, 2011Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
124
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •- Written informed consent obtained from the patient/parents or legally acceptable representative
  • •- Paediatric patients, age >/=3 years and <18 years
  • •- Newly diagnosed localized, supratentorial- or infratentorial cerebellar or peduncular, WHO Grade III or IV gliomas
  • •- Local histological diagnosis confirmed by a designated central reference neuropathologist
  • •- Availability of a baseline MRI performed according to imaging guidelines
  • •- Able to commence trial treatment not before 4 weeks after cranial surgery and no later than 6 weeks following the last major surgery
  • •- Adequate bone marrow, coagulation, liver, renal function
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 130
  • •F.1.2 Adults (18-64 years) no
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •- Metastatic (HGG) defined as evidence of neuraxis dessimination by MRI or positive CSF cytology
  • •- WHO-defined Gliomatosis cerebri (multifocal HGG)
  • •- Any disease or condition that contraindicates the use of the study medication/treatment or places the patient at an unacceptable risk of experiencing treatment-related complications
  • •- Radiological evidence of surgically related intracranial bleeding
  • •- Prior diagnosis of a malignancy and disease-free for 5 years
  • •- Prior systemic anti-cancer therapy
  • •- Previous cranial irradiation

Investigators

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Treatment of children with newly diagnosed... | Clinical Trial