Phase II Cisplatin + Temozolomide in Malignant Glial Tumours in Children and Adolescents

Phase 2

Completed

• Conditions: Glioma

• Registration Number: NCT00147160
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary

The purpose of this study is to determine whether the combination of Temozolomide and Cisplatinum is effective in the treatment of malignant glial tumours of children and adolescents

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-07
• Primary Completion: 2006-07
• Status Verified: 2006-09
• Study Completion: 2007-12
• Last Update Submitted: 2012-04-10
• Last Update Posted: 2012-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

• Age from 4th birthday and younger than 21st birthday
• Histologically documented malignant glial tumour (WHO classification grade III and IV) : astrocytoma, oligodendroglioma, oligoastrocytoma and mixed tumours
• Measurable and evaluable disease by the imaging criteria (MRI)
• Patient not previously treated by either of the two drugs

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Exclusion Criteria

• Malignant brain stem tumours are excluded

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Radiological response after two courses of Temozolomide-Cisplatinum

Secondary Outcome Measures

Name	Time	Method
Progression-free survival
Health status and quality of life
Toxicity

Trial Locations

Locations (2)

Institut Gustave-Roussy; 🇫🇷 Villejuif, France

Bristol Royal Hospital for Children; 🇬🇧 Bristol, United Kingdom