Austrian Registry for Evaluation of Treatment Patterns and Outcome in Patients With Advanced Pancreatic Ductal Adenocarcinoma (PDAC)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedical University of Graz

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • all approved chemotherapeutic agents from second line

    Drug

    all approved chemotherapeutic agents from second line

Treatment groups

1,500 Participants
are divided into 1 treatment group
Group A: Patient with locally advanced inoperable and/or metastatic pancreatic ductal adenocarcinoma1 intervention

Trial outcomes

Primary outcomes

1

Proportion of patients with locally advanced inoperable and/or metastatic PDAC undergoing palliative second line therapy after progression on first line chemotherapy

Time frame
24 months

Secondary outcomes

1

To identify prognostic and predictive features for treatment efficacy

Time frame
24 months
2

To identify prognostic and predictive features for clinical outcome

Time frame
24 months
3

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

Time frame
24 months
4

To identify prognostic and predictive features for Febrile Neuropathy

Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented

Time frame
24 months

Other outcomes

Sponsors and contacts

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