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PRODIGE 69 – FOLFIRINEC - FOLFIRINOX versus PLATINUM - ETOPOSIDE as first line chemotherapy for metastatic grade 3 poorly differentiated neuroendocrine carcinoma of gastro entero pancreatic and unknown primary associated with molecular profiling for therapeutic targets & predictive biomarkers identification

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515300-39-00
Acronym
PRODIGE69
Enrollment
218
Registered
2024-10-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

METASTATIC GRADE 3 POORLY DIFFERENTIATED NEUROENDOCRINE CARCINOMA OF GASTRO ENTERO PANCREATIC AND UNKNOWN PRIMARY

Brief summary

To compare the progression-free survival (PFS) with mFOLFIRINOX regimen versus platinum - etoposide regimen according to the investigator using RECIST v1.1 criteria.

Detailed description

PFS according to the centralized review (RECIST v1.1 criteria), Best objective response rate (ORR), Median overall survival (OS), Safety according to NCI CTC V4.0, Dose-reductions, Quality of life assessed by EORTC QLQ-C30 and EQ-5D-5L, To establish a molecular profile within 2 months after tumor sample submission for each patient enrolled in the study anmolecular tumor board report to the treating physician.d to provide a, Frequency of Rb loss in G3 NEC irrespective of the SC or LC subtype, Correlation of ORR, PFS and OS under both chemotherapy regimens with molecular alterations (Rb, TP53, MSH2…)

Interventions

DRUGOXALIPLATINE HOSPIRA 5 mg/ml
DRUGsolution à diluer pour perfusion
DRUGIrinotecan Kabi 20 mg/ml concentrate for solution for infusion
DRUGETOPOSIDE TEVA 200 mg/10 ml
DRUGsolution injectable pour perfusion
DRUGFLUOROURACILE TEVA 1000 mg/20 ml
DRUGCisplatine Teva 1 mg/ml concentraat voor oplossing voor infusie.

Sponsors

Centre Hospitalier Universitaire De Dijon
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
To compare the progression-free survival (PFS) with mFOLFIRINOX regimen versus platinum - etoposide regimen according to the investigator using RECIST v1.1 criteria.—

Secondary

MeasureTime frame
PFS according to the centralized review (RECIST v1.1 criteria), Best objective response rate (ORR), Median overall survival (OS), Safety according to NCI CTC V4.0, Dose-reductions, Quality of life assessed by EORTC QLQ-C30 and EQ-5D-5L, To establish a molecular profile within 2 months after tumor sample submission for each patient enrolled in the study anmolecular tumor board report to the treating physician.d to provide a, Frequency of Rb loss in G3 NEC irrespective of the SC or LC subtype, Correlation of ORR, PFS and OS under both chemotherapy regimens with molecular alterations (Rb, TP53, MSH2…)—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026