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

Gustave Roussy, Cancer Campus, Grand Paris87 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glioma

Interventions

Temozolomide, CisplatinumDRUG

Eligibility

Sex: ALLMin age: 4 YearsMax age: 21 Years

Medical Language ↔ Plain English

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 Exclusion Criteria: * Malignant brain stem tumours are excluded

Locations (2)

Institut Gustave-Roussy

Villejuif, France

Bristol Royal Hospital for Children

Bristol, United Kingdom

Outcomes

Primary Outcomes

Radiological response after two courses of Temozolomide-Cisplatinum

Secondary Outcomes

Progression-free survival

Health status and quality of life

Toxicity

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.