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Randomized Crossover Trial to Assess the Effects and Quality of Life in Patients With Locally Advanced or Metastatic Pancreatic Cancer Treated With Gemcitabine in Combination With Nab-paclitaxel: QOLINPAC
This was a quality of life (QOL) study done in the context of a randomized trial in locally advanced or metastatic pancreatic cancer. Eligible patients were randomized to receive either the combination of nab-paclitaxel/gemcitabine or standard gemcitabine monotherapy. The combination regimen of nab-paclitaxel and gemcitabine showed improved efficacy with acceptable toxicity in this disease setting in first-line and was approved for this indication. The study design allowed patients in standard treatment to receive the combination treatment after first tumour progression. The proposed study explored the impact of treatment on the QOL scores and compared the times to definitive deterioration of the QOL scores using the validated EORTC QLQ-C30 questionnaire. Efficacy and safety were secondary endpoints and were reported descriptively. Molecular studies will be performed on blood and tissue samples as avaialble and will be reported separately.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
OLV Ziekenhuis Aalst
Aalst, Belgium
AZ Klina
Brasschaat, Belgium
AZ St Lucas
Bruges, Belgium
ULB Hôpital Erasme
Brussels, Belgium
Cliniques Universitaires St Luc
Brussels, Belgium
CHU de Charleroi
Charleroi, Belgium
UZ Antwerpen
Edegem, Belgium
AZ Maria Middelares
Ghent, Belgium
UZ Gent
Ghent, Belgium
UZ Leuven
Leuven, Belgium
Start Date
April 1, 2014
Primary Completion Date
April 29, 2019
Completion Date
April 29, 2019
Last Updated
November 6, 2019
146
ACTUAL participants
Nab-paclitaxel
DRUG
Gemcitabine
DRUG
Lead Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
NCT04550494
NCT05053971
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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