Clinical trialObsRecruiting
Austrian Registry for Evaluation of Treatment Patterns and Outcome in Patients With Advanced Pancreatic Ductal Adenocarcinoma (PDAC)
- Outcome
- Ongoing
- Phase
- Obs
- Status
- Recruiting
- Study type
- Observational
- Start
- 13 January 2023
- Expected end
- December 2027
- Enrollment
- 1,500 participants
- Sites
- 14
- Primary outcomes
- Proportion of patients with locally advanced inoperable and/or metastatic PDAC undergoing palliative second line therapy after progression on first line chemotherapy
- Sponsor
- Other
- Results posted
- No
- Last update
- 1 September 2026
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
1500 adult patients with locally advanced inoperable and/or metastasized PDAC undergoing first line chemotherapy
Intervention public domain (ClinicalTrials.gov)
Drug: all approved chemotherapeutic agents from second line. all approved chemotherapeutic agents from second line
Arm public domain (ClinicalTrials.gov)
Patient with locally advanced inoperable and/or metastatic pancreatic ductal adenocarcinoma (): Patient with locally advanced inoperable and/or metastatic pancreatic ductal adenocarcinoma
Primary outcome public domain (ClinicalTrials.gov)
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 outcome public domain (ClinicalTrials.gov)
To identify prognostic and predictive features for treatment efficacy. Time frame: 24 months.
Secondary outcome public domain (ClinicalTrials.gov)
To identify prognostic and predictive features for clinical outcome. Time frame: 24 months.
Secondary outcome public domain (ClinicalTrials.gov)
To identify prognostic and predictive features for Neuropathy. Time frame: 24 months.
Secondary outcome public domain (ClinicalTrials.gov)
To identify prognostic and predictive features for Febrile Neuropathy. Time frame: 24 months.
Secondary outcome public domain (ClinicalTrials.gov)
To identify prognostic and predictive features for Thrombocytopenia. Time frame: 24 months.
Secondary outcome public domain (ClinicalTrials.gov)
To identify prognostic and predictive features for Anemia. Time frame: 24 months.
Eligibility public domain (ClinicalTrials.gov)
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
Enrollment public domain (ClinicalTrials.gov)
Enrollment: 1500 participants (estimated).