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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
1500 adult patients with locally advanced inoperable and/or metastasized PDAC undergoing first line chemotherapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with locally advanced inoperable and/or metastatic pancreatic ductal adenocarcinoma | Patient with locally advanced inoperable and/or metastatic pancreatic ductal adenocarcinoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| all approved chemotherapeutic agents from second line | Drug | all approved chemotherapeutic agents from second line |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To identify prognostic and predictive features for treatment efficacy | 24 months | |
| To identify prognostic and predictive features for clinical outcome | 24 months | |
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Inclusion Criteria:
Exclusion Criteria:
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1500 adult patients with locally advanced inoperable and/or metastasized PDAC undergoing first line therapy with a platinum- or gemcitabin- based chemotherapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Armin Gerger, Univ.Prof.Dr | Contact | +43 316 385 13115 | armin.gerger@medunigraz.at | |
| Karin Groller, MPH | Contact | +43 316 385 14174 | karin.groller@medunigraz.at |
| Name | Affiliation | Role |
|---|---|---|
| Jakob Riedl, Priv.Doz. Dr. | Medical University of Graz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Graz Department of Oncology | Recruiting | Graz | Styria | 8036 | Austria |
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| 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 |
| 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 | 24 months |
| To identify prognostic and predictive features for Thrombocytopenia | Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented | 24 months |
| To identify prognostic and predictive features for Anemia | Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented | 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 | 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 | 24 months |
| To identify prognostic and predictive features for rash | Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented | 24 months |
| To identify prognostic and predictive features for mucositis | Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented | 24 months |
| To identify prognostic and predictive features for Fatigue | Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented | 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 | 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 | 24 months |
| 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 |
| Ordensklinikum Linz | Recruiting | Linz | Upper Austria | 4010 | Austria |
|
| Landesklinikum Amstetten | Recruiting | Amstetten | 3300 | Austria |
|
| Landesklinikum Feldkirch | Recruiting | Feldkirch | 6800 | Austria |
|
| Krankenhaus der Barmherzigen Brüder | Recruiting | Graz | 8020 | Austria |
|
| Universitätsklinikum Innsbruck, | Recruiting | Innsbruck | 6020 | Austria |
|
| Landesklinikum Klagenfurt | Recruiting | Klagenfurt | 9020 | Austria |
|
| Universitätsklinikum St. Pölten | Recruiting | Sankt Pölten | 3100 | Austria |
|
| Barmherzige Schwestern Krankenhaus Wien | Recruiting | Vienna | 1060 | Austria |
|
| Pancreatic Cancer Unit des Comprehensive Cancer Center (CCC-PCU) | Recruiting | Vienna | 1090 | Austria |
|
| St. Josef Krankenhaus Wien | Recruiting | Vienna | 1130 | Austria |
|
| Krankenhaus St. Vinzenz Zams | Recruiting | Zams | 6511 | Austria |
|
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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