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Chemoradiotherapy With 5-Fluorouracil and Maintenance Chemotherapy for High-Risk Posterior Fossa Ependymoma
NCT07848568Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- Dec 2026
- Primary completion
- Jun 2037
- Sponsor
- Children's Oncology Group
- Conditions
- ependymoma
01
Overview
Phase 2, open-label, single-arm trial of fluorouracil and tretinoin in ependymoma, sponsored by Children's Oncology Group. Primary endpoints: Occurrence of dose limiting toxicity chemoradiotherapy, Occurrence of DLT for maintenance therapy up to 42 days and 1 more. Planned start Dec 2026; status: not yet recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Treatment (radiation, fluorouracil, tretinoin)
Chemoradiotherapy followed by maintenance chemotherapy
03
Who it enrols
Children and young adults (1-20 years) with newly diagnosed, localized, high-risk posterior fossa ependymoma (group PFA) with specific molecular features, adequate organ function, and no metastatic disease.
04
Endpoints
Primary
Occurrence of dose limiting toxicity chemoradiotherapy
Occurrence of DLT for maintenance therapy
Event free survival
Secondary
Overall response
Overall survival
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