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QOLINPAC: Nab-paclitaxel + Gemcitabine in Pancreatic Cancer
NCT02106884Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2014
- Primary completion
- Apr 2019
- Countries
- 1
- Sponsor
- UZ Leuven
- Modality
- Small Molecules
- Drugs
- paclitaxel
- Conditions
- pancreatic cancer (PC)
01
Overview
Phase 2, randomised, open-label trial of paclitaxel in pancreatic cancer (PC), sponsored by UZ Leuven. Primary endpoints: Deterioration-free Survival Rate of the QOL Global Health Status at 12 months and QOL Global Health Status Deterioration-free Median Survival up to 3 years. Started Apr 2014; status: completed.
02
Design
- Study design
- RandomizedOpen-label
03
Who it enrols
Adult patients with unresectable locally advanced or metastatic pancreatic adenocarcinoma, ECOG 0-2, and no prior chemotherapy for metastatic disease.
04
Endpoints
Primary
Deterioration-free Survival Rate of the QOL Global Health Status
QOL Global Health Status Deterioration-free Median Survival
Secondary
Overall Response
Duration of Response
Disease Control
Progression Free Survival
Overall Survival
Laboratory Safety Assessment
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