Pancreatic CancerADPACANCT05526443
Austrian Registry for Evaluation of Treatment Patterns and Outcome in Patients With Advanced Pancreatic Ductal Adenocarcinoma (PDAC)
An observational study of Pancreatic Cancer and Advanced Pancreatic Carcinoma, run by Medical University of Graz at 14 sites in Austria.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Advanced Pancreatic Carcinoma
- What is being tested?
- all approved chemotherapeutic agents from second line
- How many people
- 1,500 participants
- Where
- 14 sitesAustria
- Study dates
- 13 Jan 2023to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1500 adult patients with locally advanced inoperable and/or metastasized PDAC undergoing first line therapy with a platinum- or gemcitabin- based chemotherapy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
Austria14 sites, 14 recruiting
- Recruiting
Landesklinikum Amstetten
Amstetten, 3300
Armin Gerger, Univ. Prof. Dr., Armin.Gerger@amstetten.lknoe.at
- Recruiting
Landesklinikum Feldkirch
Feldkirch, 6800
Thomas Winder, PD. Dr., Thomas.Winder@lkhf.at
- Recruiting
Medical University Graz Department of Oncology
Graz, Styria, 8036
Jakob Riedl, Priv. Doz. Dr. Dr., +43 316 385 32015, j.riedl@medunigraz.at
Karin Groller, MPH, +43 316 385 14174, karin.groller@medunigraz.at
- Recruiting
Krankenhaus der Barmherzigen Brüder
Graz, 8020
Daniel Mayer, Dr.
DanielMaria.Mayer@bbgraz.at
- Recruiting
Universitätsklinikum Innsbruck,
Innsbruck, 6020
Angela Djanani, Dr., Angela.djanani@i-med.ac.at
- Recruiting
Landesklinikum Klagenfurt
Klagenfurt, 9020
Wolfgang Eisterer, Univ. Prof. Dr.
wolfgang.eisterer@kabeg.at
- Recruiting
Ordensklinikum Linz
Linz, Upper Austria, 4010
Holger Rumpold, PD MD, holger.rumpold@ordensklinikum.at
- Recruiting
Kepler University Hospital
Linz, 4020
Gudrun Piringer, Priv. Doz. Dr., Gudrun.Piringer@kepleruniklinikum.at
- Recruiting
Salzburg State Hospital, PMU University Clinic
Salzburg, 5020
Konstantin Schlick, Priv. Doz. Dr., Schlick Konstantin <k.schlick@salk.at>
- Recruiting
Universitätsklinikum St. Pölten
Sankt Pölten, 3100
Hossein Taghizadeh, Dr. PhD, Hossein.Taghizadeh@stpoelten.lknoe.at
- Recruiting
Barmherzige Schwestern Krankenhaus Wien
Vienna, 1060
Leopold Öhler, Univ. Prof. Dr., Leopold.Oehler@bhs.at
- Recruiting
Pancreatic Cancer Unit des Comprehensive Cancer Center (CCC-PCU)
Vienna, 1090
Gerald Prager, Assoz. Prof. PD. Dr., gerald.prager@meduniwien.ac.at
- Recruiting
St. Josef Krankenhaus Wien
Vienna, 1130
Leopold Öhler, Univ. Prof. Dr., leopold.oehler@sjk-wien.at
- Recruiting
Krankenhaus St. Vinzenz Zams
Zams, 6511
Ewald Wöll, Univ.Prof. Dr., Ewald.Woell@krankenhaus-zams.at
About this study
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
Read the detailed description
1500 adult patients with locally advanced inoperable and/or metastasized PDAC undergoing first line chemotherapy
- Conditions
- Pancreatic Cancer, Advanced Pancreatic Carcinoma
- Being tested
- all approved chemotherapeutic agents from second line
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
all approved chemotherapeutic agents from second lineDrug
all approved chemotherapeutic agents from second line
| Study group | Role | What they receive |
|---|---|---|
| Patient with locally advanced inoperable and/or metastatic pancreatic ductal adenocarcinoma | Patient with locally advanced inoperable and/or metastatic pancreatic ductal adenocarcinoma Receives: Drug: all approved chemotherapeutic agents from second line |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with locally advanced inoperable and/or metastatic PDAC undergoing palliative second line therapy after progression on first line chemotherapy
Measured: 24 months
Secondary outcomes (35)
To identify prognostic and predictive features for treatment efficacy
Measured: 24 months
To identify prognostic and predictive features for clinical outcome
Measured: 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
Measured: 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
Measured: 24 months
To identify prognostic and predictive features for Thrombocytopenia
Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented
Measured: 24 months
To identify prognostic and predictive features for Anemia
Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented
Measured: 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
Measured: 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
Measured: 24 months
To identify prognostic and predictive features for rash
Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented
Measured: 24 months
To identify prognostic and predictive features for mucositis
Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented
Measured: 24 months
To identify prognostic and predictive features for Fatigue
Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented
Measured: 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
Measured: 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
Measured: 24 months
To investigate the effect of dose density on treatment efficacy of first- and second line therapy
Measured: 24 months
To investigate the effect of dose modifications on treatment efficacy of first- and second line therapy
Measured: 24 months
To perform a comparative effectiveness analysis of different palliative second line chemotherapy regimens
Measured: 24 months
To evaluate treatment behaviours after progression on palliative second line therapy
Measured: 24 months
To analyse efficacy of palliative third line therapy
Measured: 24 months
To analyse patterns of BRCA testing in real-world practice
Measured: 24 months
To analyse the impact of BRCA testing in real-world practice on treatment decisions
Measured: 24 months
To analyse the impact of BRCA testing in real-world practice on outcome
Measured: 24 months
Prevalence of primary tumor resection in patients with metastatic or locally advanced inoperable pancreatic cancer
Measured: 24 months
Prevalence of metastasectomy in patients with metastatic or locally advanced inoperable pancreatic cancer
Measured: 24 months
To evaluate the impact of primary tumor resection on outcome
Measured: 24 months
To evaluate the impact of metastasectomy on outcome
Measured: 24 months
To evaluate the impact of primary granulocyte-colony stimulating factor (G-CSF) use on dose density of FOLFIRINOX
Measured: 24 months
To evaluate the impact of primary granulocyte-colony stimulating factor (G-CSF) use on rate of febrile neutropenia
Measured: 24 months
To evaluate the impact of primary granulocyte-colony stimulating factor (G-CSF) use on overall outcome
Measured: 24 months
To evaluate patterns of molecular profiling in the real world treatment practice of advanced pancreatic cancer
Measured: 24 months
To evaluate patterns of next generation sequencing (NGS) in the real world treatment practice of advanced pancreatic cancer
Measured: 24 months
To analyse treatment patterns and outcome in the subgroup of very young (<40 years old) patients with advanced pancreatic cancer
Measured: 24 months
To analyse treatment patterns and outcome in the subgroup of very old (>75 years old) patients with advanced pancreatic cancer
Measured: 24 months
To investigate the impact of diabetes mellitus on treatment efficacy of palliative chemotherapy and disease outcome
Measured: 24 months
To investigate the impact of antidiabetic therapy on treatment efficacy of palliative chemotherapy and disease outcome
Measured: 24 months
To analyze the mutational landscape of advanced pancreatic cancer and its impact on treatment decision making and clinical outcome
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start13 Jan 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jakob M Riedl, Pri. Doz. Dr. Dr., Principal investigator, Medical University Graz Department of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526443
- Sponsor's protocol ID
- ADPACA
- Acronym
- ADPACA
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2022
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Austrian Registry for Evaluation of Treatment Patterns and Outcome in Patients With Advanced Pancreatic Ductal Adenocarcinoma (PDAC)
- ClinicalTrials.gov ID
- NCT05526443
- Acronym / sponsor ID
- ADPACA / ADPACA
- Conditions
- Pancreatic Cancer, Advanced Pancreatic Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with locally advanced inoperable and/or metastatic pancreatic ductal adenocarcinoma | – | Drug: all approved chemotherapeutic agents from second linePatient with locally advanced inoperable and/or metastatic pancreatic ductal adenocarcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1500 adult patients with locally advanced inoperable and/or metastasized PDAC undergoing first line therapy with a platinum- or gemcitabin- based chemotherapy
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| all approved chemotherapeutic agents from second lineall approved chemotherapeutic agents from second line | Drug | Patient with locally advanced inoperable and/or metastatic pancreatic ductal adenocarcinoma |
Primary outcome
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
35 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
To identify prognostic and predictive features for Febrile Neuropathy
Time frame: 24 months
To identify prognostic and predictive features for Thrombocytopenia
Time frame: 24 months
To identify prognostic and predictive features for Anemia
Time frame: 24 months
To identify prognostic and predictive features for Nausea/Vomiting
Time frame: 24 months
To identify prognostic and predictive features for Skin toxicity
Time frame: 24 months
To identify prognostic and predictive features for rash
Time frame: 24 months
To identify prognostic and predictive features for mucositis
Time frame: 24 months
To identify prognostic and predictive features for Fatigue
Time frame: 24 months
To identify prognostic and predictive features for Allergic reactions
Time frame: 24 months
To identify prognostic and predictive features for all other Adverse Events
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jakob M Riedl, Pri. Doz. Dr. Dr. principal investigator
Medical University Graz Department of Oncology
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Advanced Pancreatic Carcinoma, run by Medical University of Graz at 14 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jakob M Riedl, Priv. Doz. Dr. Dr. (+43 316 385 32015, j.riedl@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.