Austrian Registry For Evaluation Of Treatment Patterns And Outcome In Patients With Advanced Pancreatic Ductal Adenocarcinoma (PDAC)

Study Overview

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

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

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

Pancreatic Cancer
Advanced Pancreatic Carcinoma

DRUG: all approved chemotherapeutic agents from second line

ADPACA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-08-31	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-03-13
First Submitted that Met QC Criteria 2022-08-31	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-03-18
First Posted (ACTUAL) 2022-09-02	Results First Posted N/A	Last Verified 2025-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: Patient with locally advanced inoperable and/or metastatic pancreatic ductal adenocarcinoma 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

Participant Group/Arm

Intervention/Treatment

: Patient with locally advanced inoperable and/or metastatic pancreatic ductal adenocarcinoma

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

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Armin Gerger, Univ.Prof.Dr

Phone Number:

Email: armin.gerger@medunigraz.at

Study Contact Backup

Name: Karin Groller, MPH

Phone Number: +43 316 385 14174

Email: karin.groller@medunigraz.at

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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