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

Medical University of Graz1,500 enrolled

Overview

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

1500 adult patients with locally advanced inoperable and/or metastasized PDAC undergoing first line chemotherapy

Study Type

OBSERVATIONAL

Enrollment

1,500

Conditions

Pancreatic Cancer Advanced Pancreatic Carcinoma

Interventions

all approved chemotherapeutic agents from second lineDRUG

all approved chemotherapeutic agents from second line

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (14)

Medical University Graz Department of Oncology

Graz, Styria, Austria

RECRUITING

Ordensklinikum Linz

Linz, Upper Austria, Austria

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

Time frame: 24 months

Secondary Outcomes

To identify prognostic and predictive features for treatment efficacy

Time frame: 24 months

To identify prognostic and predictive features for clinical outcome

Time frame: 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

Time frame: 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

Time frame: 24 months

To identify prognostic and predictive features for Thrombocytopenia

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

Time frame: 24 months

To identify prognostic and predictive features for Anemia

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

Time frame: 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

Central Contacts

Jakob M Riedl, Priv. Doz. Dr. Dr.

CONTACT

+43 316 385 32015 j.riedl@medunigraz.at

Karin Groller, MPH

CONTACT

+43 316 385 14174 karin.groller@medunigraz.at

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Landesklinikum Amstetten

Amstetten, Austria

RECRUITING

Landesklinikum Feldkirch

Feldkirch, Austria

RECRUITING

Krankenhaus der Barmherzigen Brüder

Graz, Austria

RECRUITING

Universitätsklinikum Innsbruck,

Innsbruck, Austria

RECRUITING

Landesklinikum Klagenfurt

Klagenfurt, Austria

RECRUITING

Kepler University Hospital

Linz, Austria

RECRUITING

Salzburg State Hospital, PMU University Clinic

Salzburg, Austria

RECRUITING

Universitätsklinikum St. Pölten

Sankt Pölten, Austria

RECRUITING

...and 4 more locations

Time frame: 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

Time frame: 24 months

To identify prognostic and predictive features for rash

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

Time frame: 24 months

To identify prognostic and predictive features for mucositis

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

Time frame: 24 months

To identify prognostic and predictive features for Fatigue

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

Time frame: 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

Time frame: 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

Time frame: 24 months

To investigate the effect of dose density on treatment efficacy of first- and second line therapy

Time frame: 24 months

To investigate the effect of dose modifications on treatment efficacy of first- and second line therapy

Time frame: 24 months

To perform a comparative effectiveness analysis of different palliative second line chemotherapy regimens

Time frame: 24 months

To evaluate treatment behaviours after progression on palliative second line therapy

Time frame: 24 months

To analyse efficacy of palliative third line therapy

Time frame: 24 months

To analyse patterns of BRCA testing in real-world practice

Time frame: 24 months

To analyse the impact of BRCA testing in real-world practice on treatment decisions

Time frame: 24 months

To analyse the impact of BRCA testing in real-world practice on outcome

Time frame: 24 months

Prevalence of primary tumor resection in patients with metastatic or locally advanced inoperable pancreatic cancer

Time frame: 24 months

Prevalence of metastasectomy in patients with metastatic or locally advanced inoperable pancreatic cancer

Time frame: 24 months

To evaluate the impact of primary tumor resection on outcome

Time frame: 24 months

To evaluate the impact of metastasectomy on outcome

Time frame: 24 months

To evaluate the impact of primary granulocyte-colony stimulating factor (G-CSF) use on dose density of FOLFIRINOX

Time frame: 24 months

To evaluate the impact of primary granulocyte-colony stimulating factor (G-CSF) use on rate of febrile neutropenia

Time frame: 24 months

To evaluate the impact of primary granulocyte-colony stimulating factor (G-CSF) use on overall outcome

Time frame: 24 months

To evaluate patterns of molecular profiling in the real world treatment practice of advanced pancreatic cancer

Time frame: 24 months

To evaluate patterns of next generation sequencing (NGS) in the real world treatment practice of advanced pancreatic cancer

Time frame: 24 months

To analyse treatment patterns and outcome in the subgroup of very young (<40 years old) patients with advanced pancreatic cancer

Time frame: 24 months

To analyse treatment patterns and outcome in the subgroup of very old (>75 years old) patients with advanced pancreatic cancer

Time frame: 24 months

To investigate the impact of diabetes mellitus on treatment efficacy of palliative chemotherapy and disease outcome

Time frame: 24 months

To investigate the impact of antidiabetic therapy on treatment efficacy of palliative chemotherapy and disease outcome

Time frame: 24 months

To analyze the mutational landscape of advanced pancreatic cancer and its impact on treatment decision making and clinical outcome

Time frame: 24 months