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

NCT ID: NCT00147160

Last Updated: 2012-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2007-12-31

Brief Summary

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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

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Conditions

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Glioma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Temozolomide, Cisplatinum

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacques Grill, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Gustave Roussy, Cancer Campus, Grand Paris

Locations

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Institut Gustave-Roussy

Villejuif, , France

Site Status

Bristol Royal Hospital for Children

Bristol, , United Kingdom

Site Status

Countries

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France United Kingdom

Other Identifiers

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CSET-2002/978

Identifier Type: -

Identifier Source: secondary_id

CISTEM2

Identifier Type: -

Identifier Source: org_study_id

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