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A randomized phase III trial of short-course versus long-course pre-operative chemotherapy with mFOLFIRINOX or PAXG regimen for stage I-III pancreatic ductal adenocarcinoma (PDAC)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519031-42-00
Acronym
PACT-21/CASSANDRA
Enrollment
261
Registered
2024-11-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-18

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

Conditions

pancreatic ductal adenocarcinoma

Brief summary

EFS, defined as the time from randomization to: RECIST 1.1 progression [At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study

Detailed description

OS, RECIST 1.1 response rate, CA19.9 response rate, complete pathologic response, resectability rate, surgical mortality and morbidity rate, intra- and post-operative metastasis rate, N0 and R0 resections rate, patients reported outcomes, treatment toxicity

Interventions

DRUGAbraxane 5 mg/ml powder for dispersion for infusion.
DRUGcomprimé pelliculé
DRUGsolution à diluer pour perfusion
DRUGOxaliplatino Aurovit 5 mg/ml concentrado para solución para perfusión EFG
DRUGFluorouracil/Anabiosis 50 mg/ml διάλυμα για ένεση ή έγχυση

Sponsors

Associazione Italiana Per Lo Studio Del Pancreas
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
EFS, defined as the time from randomization to: RECIST 1.1 progression [At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study

Secondary

MeasureTime frame
OS, RECIST 1.1 response rate, CA19.9 response rate, complete pathologic response, resectability rate, surgical mortality and morbidity rate, intra- and post-operative metastasis rate, N0 and R0 resections rate, patients reported outcomes, treatment toxicity

Countries

Italy

Outcome results

None listed

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