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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05526443

Acronym

ADPACA

Enrollment

1500

Registered

2022-09-02

Start date

2023-01-13

Completion date

2027-12-01

Last updated

2026-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Pancreatic Carcinoma, Pancreatic Cancer

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

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

Interventions

DRUGall approved chemotherapeutic agents from second line

all approved chemotherapeutic agents from second line

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Measure	Time frame	Description
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	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	24 months	Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented
To identify prognostic and predictive features for Thrombocytopenia	24 months	Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented
To identify prognostic and predictive features for Anemia	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	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	24 months	Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented
To identify prognostic and predictive features for rash	24 months	Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented
To identify prognostic and predictive features for mucositis	24 months	Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented
To identify prognostic and predictive features for Fatigue	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	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	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	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	—

Countries

Austria

Contacts

CONTACTJakob M Riedl, Priv. Doz. Dr. Dr.

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

CONTACTKarin Groller, MPH

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

PRINCIPAL_INVESTIGATORJakob M Riedl, Pri. Doz. Dr. Dr.

Medical University Graz Department of Oncology

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026