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FOLFIRINOX vs Platinum-Etoposide in Metastatic G3 NEC
NCT04325425Phase 2
Key facts
- Status
- Recruiting
- Start
- Sep 2020
- Primary completion
- Sep 2029
- Countries
- 1
- Sponsor
- Centre Hospitalier Universitaire Dijon Bourgogne
- Modality
- Nanoparticles, Monoclonal Antibodies, DNA Intercalators/Alkylators
- Drugs
- fluorouracilirinotecan hydrochloride liposome injection (II) + temozolomide + bevacizumaboxaliplatin
- Conditions
- neuroendocrine carcinoma (NEC)
01
Overview
Phase 2, randomised, open-label trial of fluorouracil, irinotecan hydrochloride liposome injection (II) + temozolomide + bevacizumab and oxaliplatin in neuroendocrine carcinoma (NEC) (2 arms), sponsored by Centre Hospitalier Universitaire Dijon Bourgogne. Primary endpoint: Median Progression-Free Survival at 7.5 months. Started Sep 2020; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
mFOLFIRINOX
Fluorouracil, Leucovorin, Irinotecan, Oxaliplatin every 14 days
Platinum-Etoposide
Cisplatin or Carboplatin + Etoposide every 21 days
03
Who it enrols
Patients with metastatic Grade 3 poorly differentiated neuroendocrine carcinoma of GEP or unknown origin, ECOG 0-1, no prior systemic therapy for metastatic disease.
04
Endpoints
Primary
Median Progression-Free Survival
Secondary
Progression-Free Survival Rate
Overall Survival
Best Objective Response Rate
Safety and Tolerability Profile
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