Quality of Life in Locally Advanced or Metastatic Pancreatic Cancer Treated With Gemcitabine and Nab-paclitaxel
Status:
Completed
Trial end date:
2019-04-29
Target enrollment:
Participant gender:
Summary
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.