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A Study Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for PDAC (NALPAC)
Sponsor: Belgian Group of Digestive Oncology
Summary
A non-comparative randomized phase 2 study, evaluating the efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for metastatic pancreatic ductal adenocarcinoma (PDAC), progressive after Gemcitabine-Abraxane or Gemcitabine monotherapy
Official title: A Non-comparative Randomized Phase 2 Study, Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for Metastatic Pancreatic Ductal Adenocarcinoma (PDAC), Progressive After Gemcitabine-Abraxane or Gemcitabine Monotherapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
134
Start Date
2022-05-25
Completion Date
2027-12-31
Last Updated
2025-02-06
Healthy Volunteers
No
Interventions
Nanoliposomal irinotecan
In the control arm (Naliri) a dose of 70mg/m² is administered in combination with 5FU and leucovorin In the investigational arm (Nalirinox) a dose of 50mg/m² is administered in combination with 5FU, leucovorin and oxaliplatin
5 FU
In the control arm (Naliri) a dose of 2400 mg/m² is administered in combination with nanoliposomal irinotecan and leucovorin In the investigational arm (Nalirinox) a dose of 2400 mg/m² is administered in combination with nanoliposomal irinotecan, leucovorin and oxaliplatin
Leucovorin
In the control arm (Naliri) a dose of 400 mg/m² is administered in combination with nanoliposomal irinotecan and 5FU In the investigational arm (Nalirinox) a dose of 400 mg/m² is administered in combination with nanoliposomal irinotecan, 5FU and oxaliplatin
Oxaliplatin
Only administered in the investigational arm (Nalirinox): a dose of 60 mg/m² is administered in combination with nanoliposomal irinotecan, 5FU and Leucovorin
Locations (13)
UZ Antwerpen
Antwerp, Antwerp, Belgium
ULB Erasme
Brussels, Brussels Capital, Belgium
Cliniques Universitaires Saint-Luc UCL
Brussels, Brussels Capital, Belgium
CHC MontLégia
Liège, Liège, Belgium
AZ St-Lucas
Bruges, West-Vlaanderen, Belgium
AZ Imelda
Bonheiden, Belgium
Grand Hopital de Charleroi
Charleroi, Belgium
AZ Maria Middelares
Ghent, Belgium
University Hospital Ghent
Ghent, Belgium
Pôle Hospitalier Jolimont (HELORA)
Haine-Saint-Paul, Belgium
CHU Ambroise Paré
Mons, Belgium
CHR Namur
Namur, Belgium
AZ Turnhout
Turnhout, Belgium