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Chemotherapy for Progressive Low Grade Astrocytoma in Children
NCT00002944Phase 3
Key facts
- Status
- Completed
- Start
- Apr 1997
- Primary completion
- Feb 2006
- Countries
- 6
- Sponsor
- Children's Oncology Group
- Modality
- Monoclonal Antibodies, DNA Intercalators/Alkylators, Lipid-based Nanoparticles
- Conditions
- astrocytomaglioma
01
Overview
Phase 3, randomised, open-label trial of carboplatin, vincristine sulfate liposome injection, tioguanine, procarbazine and lomustine in astrocytoma and glioma (2 arms), sponsored by Children's Oncology Group. Primary endpoint: Event Free Survival at 5 years. Started Apr 1997; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Regimen A (CV)
Carboplatin + Vincristine
Regimen B (TPCV)
Thioguanine + Procarbazine + Lomustine + Vincristine
03
Who it enrols
Children under 10 years old with progressive low-grade astrocytoma or other eligible low-grade gliomas who have not received prior chemotherapy or radiotherapy.
04
Endpoints
Primary
Event Free Survival
Secondary
Overall Survival
Tumor Response Rate
Toxic Effects
Quality of Life
Neuropsychological Status
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