NCT05526443

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
16mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Jan 2023Sep 2027

First Submitted

Initial submission to the registry

August 31, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

January 13, 2023

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

November 21, 2025

Status Verified

March 1, 2025

Enrollment Period

4.1 years

First QC Date

August 31, 2022

Last Update Submit

November 18, 2025

Conditions

Pancreatic CancerAdvanced Pancreatic Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (35)

  • 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

  • To identify prognostic and predictive features for Febrile Neuropathy

    24 months

  • To identify prognostic and predictive features for Thrombocytopenia

    24 months

  • +30 more secondary outcomes

Study Arms (1)

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

Interventions

all approved chemotherapeutic agents from second lineDRUG

all approved chemotherapeutic agents from second line

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Medical University Graz Department of Oncology

Graz, Styria, 8036, Austria

RECRUITING

Ordensklinikum Linz

Linz, Upper Austria, 4010, Austria

RECRUITING

Landesklinikum Amstetten

Amstetten, 3300, Austria

RECRUITING

Landesklinikum Feldkirch

Feldkirch, 6800, Austria

RECRUITING

Krankenhaus der Barmherzigen Brüder

Graz, 8020, Austria

RECRUITING

Universitätsklinikum Innsbruck,

Innsbruck, 6020, Austria

RECRUITING

Landesklinikum Klagenfurt

Klagenfurt, 9020, Austria

RECRUITING

Universitätsklinikum St. Pölten

Sankt Pölten, 3100, Austria

RECRUITING

Barmherzige Schwestern Krankenhaus Wien

Vienna, 1060, Austria

RECRUITING

Pancreatic Cancer Unit des Comprehensive Cancer Center (CCC-PCU)

Vienna, 1090, Austria

RECRUITING

St. Josef Krankenhaus Wien

Vienna, 1130, Austria

RECRUITING

Krankenhaus St. Vinzenz Zams

Zams, 6511, Austria

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Jakob Riedl, Priv.Doz. Dr.

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Armin Gerger, Univ.Prof.Dr

CONTACT

+43 316 385 13115armin.gerger@medunigraz.at

Karin Groller, MPH

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2022

First Posted

September 2, 2022

Study Start

January 13, 2023

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

November 21, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

AU(12)