About this trial
To systematically collect and analyse real-world data on treatment patterns, clinical outcomes and toxicities among patients with advanced pancreatic ductal adenocarcinoma (PDAC) undergoing systematic treatment in Austria
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years, female and male
ECOG (Eastern Cooperative Oncology Group) Scale 0-2
Diagnosis of histologically confirmed locally advanced inoperable and/or metastatic PDAC
Patients undergoing palliative 1st line therapy with a platinum- or gemcitabine- based chemotherapy in case of previous (neo)adjuvant therapy also patients who receive nal-Irinotecan/5-FU/Leukovorin as palliative first line are eglible
Disqualifiers
Patients with locally advanced operable PDAC who do not receive palliative chemotherapy
Patients with locally advanced borderline resectable PDAC who do not receive palliative chemotherapy
Trial population
1500 adult patients with locally advanced inoperable and/or metastasized PDAC undergoing first line therapy with a platinum- or gemcitabin- based chemotherapy
Trial design
Cohort
Prospective
Treatments tested in this trial
all approved chemotherapeutic agents from second line
Drugall approved chemotherapeutic agents from second line
Treatment groups
Trial outcomes
Primary outcomes
Proportion of patients with locally advanced inoperable and/or metastatic PDAC undergoing palliative second line therapy after progression on first line chemotherapy
Secondary outcomes
To identify prognostic and predictive features for treatment efficacy
To identify prognostic and predictive features for clinical outcome
To identify prognostic and predictive features for Neuropathy
Relative frequency of Grade 3 and Grade 4 Adverse Events according to the Common Terminology Criteria of Adverse Events (CTCAE) will be documented
To identify prognostic and predictive features for Febrile Neuropathy
Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented
Sponsors and contacts
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