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

This study has been completed.
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris Identifier:
First received: September 6, 2005
Last updated: April 10, 2012
Last verified: September 2006
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

Condition Intervention Phase
Drug: Temozolomide, Cisplatinum
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of the Combination of Cisplatin + Temozolomide in Malignant Glial Tumours in Children and Adolescents at Diagnosis or in Relapse

Resource links provided by NLM:

Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Primary Outcome Measures:
  • Radiological response after two courses of Temozolomide-Cisplatinum

Secondary Outcome Measures:
  • Progression-free survival
  • Health status and quality of life
  • Toxicity

Estimated Enrollment: 87
Study Start Date: October 2003
Study Completion Date: December 2007
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   4 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00147160

Institut Gustave-Roussy
Villejuif, France, 94805
United Kingdom
Bristol Royal Hospital for Children
Bristol, United Kingdom, BS2 8BJ
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Principal Investigator: Jacques Grill, MD, PhD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris Identifier: NCT00147160     History of Changes
Other Study ID Numbers: CISTEM2
Study First Received: September 6, 2005
Last Updated: April 10, 2012

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 23, 2017