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Neoadjuvant FOLFIRINOX in Non-Metastatic Pancreatic Cancer
NCT03977233Phase 2
Key facts
- Status
- Recruiting
- Start
- Jun 2019
- Primary completion
- Jul 2027
- Countries
- 1
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Modality
- Nanoparticles, Monoclonal Antibodies, DNA Intercalators/Alkylators
- Drugs
- oxaliplatinfolinic acidirinotecan hydrochloride liposome injection (II) + temozolomide + bevacizumabfluorouracil
- Conditions
- pancreatic ductal adenocarcinoma (PDAC)
01
Overview
Phase 2, open-label, single-arm trial of oxaliplatin, folinic acid, irinotecan hydrochloride liposome injection (II) + temozolomide + bevacizumab and fluorouracil in pancreatic ductal adenocarcinoma (PDAC), sponsored by UNC Lineberger Comprehensive Cancer Center. Primary endpoint: Best disease control rate by PDAC subtype at 6 months. Started Jun 2019; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
SingleArm: FOLFIRINOX
Subjects receive FOLFIRINOX every 14 days for up to 12 cycles.
03
Who it enrols
Adults with untreated, non-metastatic (resectable, borderline resectable, or unresectable locally advanced) pancreatic ductal adenocarcinoma, ECOG 0-1, and adequate organ function.
04
Endpoints
Primary
Best disease control rate by PDAC subtype
Secondary
Rate of resectability
Overall survival
Progression free survival
Best objective response rate
Rate of drug-related grade 3 to 5 adverse events
R0 resection rate
Proportion of patients whose tumor/stroma subtype changes after treatment with FOLFIRINOX
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