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

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

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer; Advanced Pancreatic Carcinoma
• Intervention / Treatment: Drug: all approved chemotherapeutic agents from second line

Detailed Description

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

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Karin Groller, MPH; Phone Number: +43 316 385 14174; Email: karin.groller@medunigraz.at
• Study Contact Backup: Name: Jakob M Riedl, Priv. Doz. Dr. Dr.; Phone Number: +43 316 385 32015; Email: j.riedl@medunigraz.at

Study Locations

• Austria
  • Amstetten, Austria, 3300
    • Recruiting
    • Landesklinikum Amstetten
    • Contact: Armin Gerger, Univ. Prof. Dr.; Email: Armin.Gerger@amstetten.lknoe.at
  • Feldkirch, Austria, 6800
    • Recruiting
    • Landesklinikum Feldkirch
    • Contact: Thomas Winder, PD. Dr.; Email: Thomas.Winder@lkhf.at
  • Graz, Austria, 8020
    • Recruiting
    • Krankenhaus der Barmherzigen Brüder
    • Contact: Daniel Mayer, Dr.
    • Contact: Email: DanielMaria.Mayer@bbgraz.at
  • Innsbruck, Austria, 6020
    • Recruiting
    • Universitätsklinikum Innsbruck,
    • Contact: Angela Djanani, Dr.; Email: Angela.djanani@i-med.ac.at
  • Klagenfurt, Austria, 9020
    • Recruiting
    • Landesklinikum Klagenfurt
    • Contact: Email: wolfgang.eisterer@kabeg.at
    • Contact: Wolfgang Eisterer, Univ. Prof. Dr.
  • Linz, Austria, 4020
    • Recruiting
    • Kepler University Hospital
    • Contact: Gudrun Piringer, Priv. Doz. Dr.; Email: Gudrun.Piringer@kepleruniklinikum.at
  • Salzburg, Austria, 5020
    • Recruiting
    • Salzburg State Hospital, PMU University Clinic
    • Contact: Konstantin Schlick, Priv. Doz. Dr.; Email: Schlick Konstantin <k.schlick@salk.at>
  • Sankt Pölten, Austria, 3100
    • Recruiting
    • Universitätsklinikum St. Pölten
    • Contact: Hossein Taghizadeh, Dr. PhD; Email: Hossein.Taghizadeh@stpoelten.lknoe.at
  • Vienna, Austria, 1060
    • Recruiting
    • Barmherzige Schwestern Krankenhaus Wien
    • Contact: Leopold Öhler, Univ. Prof. Dr.; Email: Leopold.Oehler@bhs.at
  • Vienna, Austria, 1090
    • Recruiting
    • Pancreatic Cancer Unit des Comprehensive Cancer Center (CCC-PCU)
    • Contact: Gerald Prager, Assoz. Prof. PD. Dr.; Email: gerald.prager@meduniwien.ac.at
  • Vienna, Austria, 1130
    • Recruiting
    • St. Josef Krankenhaus Wien
    • Contact: Leopold Öhler, Univ. Prof. Dr.; Email: leopold.oehler@sjk-wien.at
  • Zams, Austria, 6511
    • Recruiting
    • Krankenhaus St. Vinzenz Zams
    • Contact: Ewald Wöll, Univ.Prof. Dr.; Email: Ewald.Woell@krankenhaus-zams.at
  • Styria
    • Graz, Styria, Austria, 8036
      • Recruiting
      • Medical University Graz Department of Oncology
      • Contact: Karin Groller, MPH; Phone Number: +43 316 385 14174; Email: karin.groller@medunigraz.at
      • Contact: Jakob Riedl, Priv. Doz. Dr. Dr.; Phone Number: +43 316 385 32015; Email: j.riedl@medunigraz.at
      • Principal Investigator: Jakob Riedl, Priv. Doz. Dr. Dr.
  • Upper Austria
    • Linz, Upper Austria, Austria, 4010
      • Recruiting
      • Ordensklinikum Linz
      • Contact: Holger Rumpold, PD MD; Email: holger.rumpold@ordensklinikum.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

1500 adult patients with locally advanced inoperable and/or metastasized PDAC undergoing first line therapy with a platinum- or gemcitabin- based chemotherapy

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient with locally advanced inoperable and/or metastatic pancreatic ductal adenocarcinoma	Drug: all approved chemotherapeutic agents from second line; all approved chemotherapeutic agents from second line

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Collaborators: Medical University of Vienna; Medical University Innsbruck; Krankenhaus Barmherzige Schwestern Linz; LKH Klagenfurt; Universitätsklinikum St. Pölten - NÖ Landeskliniken; Barmherzige Brüder Marschallgasse Graz
• Investigators: Principal Investigator: Jakob M Riedl, Pri. Doz. Dr. Dr., Medical University Graz Department of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: August 31, 2022
• First Submitted That Met QC Criteria: August 31, 2022
• First Posted (Actual): September 2, 2022

Study Record Updates

• Last Update Posted (Actual): September 1, 2026
• Last Update Submitted That Met QC Criteria: August 28, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Antineoplastic Agents
• Other Study ID Numbers: ADPACA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No