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

Study Overview
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Brief Summary
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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

Detailed Description
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1000 adult patients with locally advanced inoperable and/or metastasized PDAC undergoing first line chemotherapy

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

Conditions
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Pancreatic Cancer, Advanced Pancreatic Carcinoma

Intervention / Treatment
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* Drug: all approved chemotherapeutic agents from second line


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 chemotherapy Signed informed consent for prospective patients, for retrospective cases no informed consent is required Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient with locally advanced inoperable and/or metastatic pancreatic ductal adenocarcinoma<br>Patient with locally advanced inoperable and/or metastatic pancreatic ductal adenocarcinoma | Drug: all approved chemotherapeutic agents from second line<br>* all approved chemotherapeutic agents from second line<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with locally advanced inoperable and/or metastatic PDAC undergoing palliative second line therapy after progression on first line chemotherapy |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify prognostic and predictive features for treatment efficacy |  | 24 months | 
| To identify prognostic and predictive features for clinical outcome |  | 24 months | 
| 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 | 24 months | 
| To identify prognostic and predictive features for Febrile Neuropathy | Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented | 24 months | 
| To identify prognostic and predictive features for Thrombocytopenia | Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented | 24 months | 
| To identify prognostic and predictive features for Anemia | Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented | 24 months | 
| To identify prognostic and predictive features for Nausea/Vomiting | Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented | 24 months | 
| To identify prognostic and predictive features for Skin toxicity | Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented | 24 months | 
| To identify prognostic and predictive features for rash | Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented | 24 months | 
| To identify prognostic and predictive features for mucositis | Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented | 24 months | 
| To identify prognostic and predictive features for Fatigue | Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented | 24 months | 
| To identify prognostic and predictive features for Allergic reactions | Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented | 24 months | 
| To identify prognostic and predictive features for all other Adverse Events | Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented | 24 months | 
| To investigate the effect of dose density on treatment efficacy of first- and second line therapy |  | 24 months | 
| To investigate the effect of dose modifications on treatment efficacy of first- and second line therapy |  | 24 months | 
| To perform a comparative effectiveness analysis of different palliative second line chemotherapy regimens |  | 24 months | 
| To evaluate treatment behaviours after progression on palliative second line therapy |  | 24 months | 
| To analyse efficacy of palliative third line therapy |  | 24 months | 
| To analyse patterns of BRCA testing in real-world practice |  | 24 months | 
| To analyse the impact of BRCA testing in real-world practice on treatment decisions |  | 24 months | 
| To analyse the impact of BRCA testing in real-world practice on outcome |  | 24 months | 
| Prevalence of primary tumor resection in patients with metastatic or locally advanced inoperable pancreatic cancer |  | 24 months | 
| Prevalence of metastasectomy in patients with metastatic or locally advanced inoperable pancreatic cancer |  | 24 months | 
| To evaluate the impact of primary tumor resection on outcome |  | 24 months | 
| To evaluate the impact of metastasectomy on outcome |  | 24 months | 
| To evaluate the impact of primary granulocyte-colony stimulating factor (G-CSF) use on dose density of FOLFIRINOX |  | 24 months | 
| To evaluate the impact of primary granulocyte-colony stimulating factor (G-CSF) use on rate of febrile neutropenia |  | 24 months | 
| To evaluate the impact of primary granulocyte-colony stimulating factor (G-CSF) use on overall outcome |  | 24 months | 
| To evaluate patterns of molecular profiling in the real world treatment practice of advanced pancreatic cancer |  | 24 months | 
| To evaluate patterns of next generation sequencing (NGS) in the real world treatment practice of advanced pancreatic cancer |  | 24 months | 
| To analyse treatment patterns and outcome in the subgroup of very young (<40 years old) patients with advanced pancreatic cancer |  | 24 months | 
| To analyse treatment patterns and outcome in the subgroup of very old (>75 years old) patients with advanced pancreatic cancer |  | 24 months | 
| To investigate the impact of diabetes mellitus on treatment efficacy of palliative chemotherapy and disease outcome |  | 24 months | 
| To investigate the impact of antidiabetic therapy on treatment efficacy of palliative chemotherapy and disease outcome |  | 24 months | 
| To analyze the mutational landscape of advanced pancreatic cancer and its impact on treatment decision making and clinical outcome |  | 24 months |