Austrian Registry for Evaluation of Treatment Patterns and Outcome in Patients with Advanced Pancreatic Ductal Adenocarcinoma (PDAC)
- Conditions
- Pancreatic CancerAdvanced Pancreatic Carcinoma
- Interventions
- Drug: all approved chemotherapeutic agents from second line
- Registration Number
- NCT05526443
- Lead Sponsor
- Medical University of Graz
- 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
1000 adult patients with locally advanced inoperable and/or metastasized PDAC undergoing first line chemotherapy
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patient with locally advanced inoperable and/or metastatic pancreatic ductal adenocarcinoma all approved chemotherapeutic agents from second line Patient with locally advanced inoperable and/or metastatic pancreatic ductal adenocarcinoma
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 Thrombocytopenia 24 months Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented
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 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 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 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 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
Trial Locations
- Locations (7)
Ordensklinikum Linz
🇦🇹Linz, Upper Austria, Austria
Krankenhaus der Barmherzigen Brüder
🇦🇹Graz, Austria
Universitätsklinikum Innsbruck,
🇦🇹Innsbruck, Austria
Landesklinikum Klagenfurt
🇦🇹Klagenfurt, Austria
Universitätsklinikum St. Pölten
🇦🇹St. Pölten, Austria
Pancreatic Cancer Unit des Comprehensive Cancer Center (CCC-PCU)
🇦🇹Wien, Austria
Medical University Graz Department of Oncology
🇦🇹Graz, Styria, Austria