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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00147160 |
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Date of registration:
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06/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Phase II Cisplatin + Temozolomide in Malignant Glial Tumours in Children and Adolescents
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Scientific title:
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Phase II Study of the Combination of Cisplatin + Temozolomide in Malignant Glial Tumours in Children and Adolescents at Diagnosis or in Relapse |
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Date of first enrolment:
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October 2003 |
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Target sample size:
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87 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00147160 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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France
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United Kingdom
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Contacts
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Name:
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Jacques Grill, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gustave Roussy, Cancer Campus, Grand Paris |
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Key inclusion & exclusion 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
Age minimum:
4 Years
Age maximum:
21 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Glioma
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Intervention(s)
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Drug: Temozolomide, Cisplatinum
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Primary Outcome(s)
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Radiological response after two courses of Temozolomide-Cisplatinum
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Secondary Outcome(s)
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Progression-free survival
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Health status and quality of life
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Toxicity
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Secondary ID(s)
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CISTEM2
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CSET-2002/978
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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