Clinical trial NCT05526443: Austrian Registry for Evaluation of Treatment Patterns and Outcome in Patients With Advanced Pancreatic Ductal Adenocarcinoma (PDAC)
Official title: Austrian Registry for Evaluation of Treatment Patterns and Outcome in Patients With Advanced Pancreatic Ductal Adenocarcinoma (PDAC)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Cancer
Advanced Pancreatic Carcinoma
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1000 adult patients with locally advanced inoperable and/or metastasized PDAC undergoing first line therapy with a platinum- or gemcitabin- based chemotherapy

Brief summary: 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: 1000 adult patients with locally advanced inoperable and/or metastasized PDAC undergoing first line chemotherapy

Eligibility criteria: 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 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
* 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

Primary outcomes:
measure: Proportion of patients with locally advanced inoperable and/or metastatic PDAC undergoing palliative second line therapy after progression on first line chemotherapy
timeFrame: 24 months
Secondary outcomes:
measure: To identify prognostic and predictive features for treatment efficacy
timeFrame: 24 months
measure: To identify prognostic and predictive features for clinical outcome
timeFrame: 24 months
measure: To identify prognostic and predictive features for Neuropathy
timeFrame: 24 months
measure: To identify prognostic and predictive features for Febrile Neuropathy
timeFrame: 24 months
measure: To identify prognostic and predictive features for Thrombocytopenia
timeFrame: 24 months
measure: To identify prognostic and predictive features for Anemia
timeFrame: 24 months
measure: To identify prognostic and predictive features for Nausea/Vomiting
timeFrame: 24 months
measure: To identify prognostic and predictive features for Skin toxicity
timeFrame: 24 months
measure: To identify prognostic and predictive features for rash
timeFrame: 24 months
measure: To identify prognostic and predictive features for mucositis
timeFrame: 24 months
measure: To identify prognostic and predictive features for Fatigue
timeFrame: 24 months
measure: To identify prognostic and predictive features for Allergic reactions
timeFrame: 24 months
measure: To identify prognostic and predictive features for all other Adverse Events
timeFrame: 24 months
measure: To investigate the effect of dose density on treatment efficacy of first- and second line therapy
timeFrame: 24 months
measure: To investigate the effect of dose modifications on treatment efficacy of first- and second line therapy
timeFrame: 24 months
measure: To perform a comparative effectiveness analysis of different palliative second line chemotherapy regimens
timeFrame: 24 months
measure: To evaluate treatment behaviours after progression on palliative second line therapy
timeFrame: 24 months
measure: To analyse efficacy of palliative third line therapy
timeFrame: 24 months
measure: To analyse patterns of BRCA testing in real-world practice
timeFrame: 24 months
measure: To analyse the impact of BRCA testing in real-world practice on treatment decisions
timeFrame: 24 months
measure: To analyse the impact of BRCA testing in real-world practice on outcome
timeFrame: 24 months
measure: Prevalence of primary tumor resection in patients with metastatic or locally advanced inoperable pancreatic cancer
timeFrame: 24 months
measure: Prevalence of metastasectomy in patients with metastatic or locally advanced inoperable pancreatic cancer
timeFrame: 24 months
measure: To evaluate the impact of primary tumor resection on outcome
timeFrame: 24 months
measure: To evaluate the impact of metastasectomy on outcome
timeFrame: 24 months
measure: To evaluate the impact of primary granulocyte-colony stimulating factor (G-CSF) use on dose density of FOLFIRINOX
timeFrame: 24 months
measure: To evaluate the impact of primary granulocyte-colony stimulating factor (G-CSF) use on rate of febrile neutropenia
timeFrame: 24 months
measure: To evaluate the impact of primary granulocyte-colony stimulating factor (G-CSF) use on overall outcome
timeFrame: 24 months
measure: To evaluate patterns of molecular profiling in the real world treatment practice of advanced pancreatic cancer
timeFrame: 24 months
measure: To evaluate patterns of next generation sequencing (NGS) in the real world treatment practice of advanced pancreatic cancer
timeFrame: 24 months
measure: To analyse treatment patterns and outcome in the subgroup of very young (<40 years old) patients with advanced pancreatic cancer
timeFrame: 24 months
measure: To analyse treatment patterns and outcome in the subgroup of very old (>75 years old) patients with advanced pancreatic cancer
timeFrame: 24 months
measure: To investigate the impact of diabetes mellitus on treatment efficacy of palliative chemotherapy and disease outcome
timeFrame: 24 months
measure: To investigate the impact of antidiabetic therapy on treatment efficacy of palliative chemotherapy and disease outcome
timeFrame: 24 months
measure: To analyze the mutational landscape of advanced pancreatic cancer and its impact on treatment decision making and clinical outcome
timeFrame: 24 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz Department of Oncology
state: Styria
city: Linz
country: Austria
facility: Ordensklinikum Linz
state: Upper Austria
city: Graz
country: Austria
facility: Krankenhaus der Barmherzigen Brüder
city: Innsbruck
country: Austria
facility: Universitätsklinikum Innsbruck,
city: Klagenfurt
country: Austria
facility: Landesklinikum Klagenfurt
city: St. Pölten
country: Austria
facility: Universitätsklinikum St. Pölten
city: Wien
country: Austria
facility: Pancreatic Cancer Unit des Comprehensive Cancer Center (CCC-PCU)
Study officials:
References: