Recruiting

NCT Number: NCT05526443

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

Recruiting

Interested in participating?

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Key information

Conditions

Pancreatic Cancer Advanced Pancreatic Carcinoma Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University Graz Department of Oncology, Graz, Styria, Austria

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

all approved chemotherapeutic agents from second line

Drug

all approved chemotherapeutic agents from second line

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

Time frame: 24 months

Relative frequency of Grade 3 and Grade 4 Adverse Events according to the Common Terminology Criteria of Adverse Events (CTCAE) will be documented
To identify prognostic and predictive features for Febrile Neuropathy

Time frame: 24 months

Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented
To identify prognostic and predictive features for Thrombocytopenia

Time frame: 24 months

Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented
To identify prognostic and predictive features for Anemia

Time frame: 24 months

Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented
To identify prognostic and predictive features for Nausea/Vomiting

Time frame: 24 months

Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented
To identify prognostic and predictive features for Skin toxicity

Time frame: 24 months

Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented
To identify prognostic and predictive features for rash

Time frame: 24 months

Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented
To identify prognostic and predictive features for mucositis

Time frame: 24 months

Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented
To identify prognostic and predictive features for Fatigue

Time frame: 24 months

Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented
To identify prognostic and predictive features for Allergic reactions

Time frame: 24 months

Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented
To identify prognostic and predictive features for all other Adverse Events

Time frame: 24 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Armin Gerger, Univ.Prof.Dr

CONTACT

[email protected]

+43 316 385 13115

Karin Groller, MPH

CONTACT

[email protected]

+43 316 385 14174

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Acronym: ADPACA

Important dates

Study start: 2023
Primary completion: 2027
Study completion: 2027
First posted: Sep 2, 2022
Registry last updated: Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Key information

Conditions

Age range

Sex eligibility

Study type

Primary location

About this study

Who can participate

Treatment and study plan

all approved chemotherapeutic agents from second line

Primary outcomes

Proportion of patients with locally advanced inoperable and/or metastatic PDAC undergoing palliative second line therapy after progression on first line chemotherapy

Secondary outcomes

To identify prognostic and predictive features for treatment efficacy

To identify prognostic and predictive features for clinical outcome

To identify prognostic and predictive features for Neuropathy

To identify prognostic and predictive features for Febrile Neuropathy

To identify prognostic and predictive features for Thrombocytopenia

To identify prognostic and predictive features for Anemia

To identify prognostic and predictive features for Nausea/Vomiting

To identify prognostic and predictive features for Skin toxicity

To identify prognostic and predictive features for rash

To identify prognostic and predictive features for mucositis

To identify prognostic and predictive features for Fatigue

To identify prognostic and predictive features for Allergic reactions

To identify prognostic and predictive features for all other Adverse Events

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

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

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

To evaluate treatment behaviours after progression on palliative second line therapy

To analyse efficacy of palliative third line therapy

To analyse patterns of BRCA testing in real-world practice

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

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

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

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

To evaluate the impact of primary tumor resection on outcome

To evaluate the impact of metastasectomy on outcome

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

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

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

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

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

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

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

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

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

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

Study contacts

Sponsors and collaborators

Lead sponsor

Registry information

Important dates

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KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer

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