Pancreatic Neoplasms Clinical Trial
Official title:
Non-interventional Observational Post-authorization Study to Assess Clinical and Patient Reported Outcomes With Nab-paclitaxel in Combination With Gemcitabine in Routine Clinical Practice Treating Pancreatic Cancer (TRUST)
The objective of the study is to prospectively assess the use and treatment outcomes of nab-paclitaxel plus gemcitabine in pancreatic ductal adenocarcinoma in the Netherlands. Additional objectives are to monitor the incidence and reversibility of neuropathy during treatment, to assess the patient's Quality of life when treated with nab-paclitaxel/gemcitabine and to evaluate the use of resources that come with treating metastatic pancreatic cancer.
The TRUST, a prospective, non-interventional observational single arm study with
Nab-paclitaxel + Gemcitabine (NG) in pancreas carcinoma in the Netherlands, was started in
2015 to observe and register the daily use of Nab-paclitaxel. The primary objective was to
prospectively assess safety of NG in metastatic pancreatic cancer under routine clinical
practice. One of the major secondary objectives was to assess the influence of treatment with
Nab-paclitaxel + Gemcitabine on the quality of life. The goal was to include 200 patients
within a period of two year and collect their prospective data.
The study has included 44 patients in the period between October 2015 and October 2017. Of
these patients, 41% were diagnosed with metastasized disease. 54% was diagnosed with local
disease of which 18% was resectable and 36% was locally advanced. 73% of the patients with
metastasized disease were treated with NG.
Over 70% of all NG treated patients received this treatment as a fist line of care. 21% of
these patients had locally advanced pancreatic cancer. 20% of the patients had had a previous
systemic treatment. Of all NG treated patients, 66% had an ECOG performance status of 0 or 1
and 62% of the patients was 75 years or younger.
At the time the study was terminated, 6 out of the 44 patients were still treated. 14
patients had stopped treatment due to disease progression, 8 patients had stopped due to
adverse events and 7 patients had chosen to stop treatment.
The low inclusion rate, which led to a prospective study duration of 10 years, and the
heterogenicity of the study population have led to the decision to terminate the study.
Therefore, no analysis, apart from the detailed description of the study population above,
can be performed.
All patients involved have taken the time to participate in the study and have filled out
questionnaires. We would like to express our gratitude towards these patients.
We remain convinced that quality of life is an important parameter in pancreatic cancer which
should be taken into consideration in daily care of patients.
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