Cooperative multicentre study for children and adolescents with low grade glioma - SIOP-LGG 2004

Phase 1

• Conditions: ow grade glioma in children and adolescents up to the age of 25 (25th birthday); MedDRA version: 9.1 Level: LLT Classification code 10018338 Term: Glioma

• Registration Number: EUCTR2005-005377-29-GB
• Lead Sponsor: niversity Hospitals of Leicester NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-04-30
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 600

Inclusion Criteria

•Age: children and adolescents up to the completion of the 25th year of life (25th birthday).
•Histology: glioma of low grade malignancy according to ICD O Code.
•Site: intracranial and/or spinal cord primary site.
•Extent: localized or disseminated tumour.
•Associated conditions: Children are eligible for the trial regardless of the presence of associated genetic disease.
•Primary tumor diagnosis: The tumor should not be pretreated with chemotherapy or radiotherapy.
•Written informed consent.
•National and local ethical approval.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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

•Primary tumour localisation: Diffuse tumours of the pons, even if histologically an Astrocytoma Io or IIo is diagnosed.
Exception: pontine glioma IIo in NFI patients may be entered into the study.
•Special diagnosis: Patients presenting with rare intracranial neoplasms of low grade malignancy, but of non-glial origin may be treated according to this protocol but will not be included in the randomised trial.
•Previous treatment: Patients who have had treatment with chemo- or radiotherapy prior to entering the study will be evaluated separately.
•Pre-existing impairment of health status, making the conduct of the study impossible or ethically unwise.
•Pregnancy or lactation period
•NB: Concomitant medication for associated or other conditions (e.g. steroids, hormone replacement, anticonvulsants) should be recorded, but it is not an exclusion criteria.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified