OncoMatch/Clinical Trials/NCT04325425
Chemotherapy For Metastatic Grade 3 Poorly Differentiated NEuroendocrine Carcinoma Of GastroEnteroPancreatic And Unknown Primary
Is NCT04325425 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including FOLFOXIRI Protocol and Cisplatin for neuroendocrine carcinoma.
Treatment: FOLFOXIRI Protocol · Cisplatin — there is a need for improving chemotherapy regimen for metastatic G3 NEC of GEP and Unknown origin and this goal may be achieved through more "personalized" chemotherapy regimen.the hypothesis is that mFOLFIRINOX regimen could be a good candidate for challenging the platinum-etoposide regimen in patients with metastatic G3 NEC of GEP or unknown origin. Furthermore, in order to get insights in the putative predictive biomarkers of efficacy of these two regimens, an effort toward a precise molecular characterization of these tumors is required in order to be able to define which subgroup of G3 NEC needs to be treated by which chemotherapy regimen. The FOLFIRINEC trial is set up in order to try to answer these questions
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroendocrine Tumor
Biomarker criteria
Excluded: DPYD deficiency
Partial or complete Dihydropyrimidine Dehydrogenase (DPD) deficiency (uracilemia ≥ 16 ng/mL)
Disease stage
Metastatic disease required
Grade: 3
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy (carboplatin, oxaliplatin, cisplatin, etoposide, irinotecan, 5-fluorouracile)
no prior use of carboplatin, oxaliplatin, cisplatin, etoposide, irinotecan and 5-fluorouracile
Cannot have received: chemotherapy
Previously treated by chemotherapy
Cannot have received: targeted therapy
Previously treated by targeted therapy
Lab requirements
Blood counts
ANC ≥ 1.5x10^9/l, platelet ≥ 100x10^9/l and hemoglobin > 8 g/dl
Kidney function
Severe renal impairment (creatinine clearance less than 30 mL/min, MDRD) [excluded]
Liver function
Total bilirubin ≤ 1.5N, AST ≤ 2.5N, ALT≤ 2.5N or AST/ALT ≤ 5N in case of liver metastases
Cardiac function
QT/QTc interval > 450 msec for male and > 470 msec for female at EKC; K+ < LLN, Mg²+ < LLN, Ca²+ < LLN
ANC ≥ 1.5x10^9/l, platelet ≥ 100x10^9/l and hemoglobin > 8 g/dl; Total bilirubin ≤ 1.5N, AST ≤ 2.5N, ALT≤ 2.5N or AST/ALT ≤ 5N in case of liver metastases; Severe renal impairment (creatinine clearance less than 30 mL/min, MDRD) [excluded]; QT/QTc interval > 450 msec for male and > 470 msec for female at EKC; K+ < LLN, Mg²+ < LLN, Ca²+ < LLN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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