Austrian Registry for Evaluation of Treatment Patterns and Outcome in Patients With Advanced Pancreatic Ductal Adenocarcinoma (PDAC)

Pancreatic Cancer Clinical Trial

— ADPACA  

Official title:

Austrian Registry for Evaluation of Treatment Patterns and Outcome in Patients With Advanced Pancreatic Ductal Adenocarcinoma (PDAC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05526443
• Other study ID #: ADPACA
• Status: Recruiting
• Start date: January 13, 2023
• Est. completion date: October 2025

Study information

• Verified date: April 2023
• Source: Medical University of Graz
• Contact: Jakob Riedl, Dr.Dr.
• Phone: +43 316 385 31256
• Email: j.riedl[@]medunigraz.at
• Is FDA regulated: No
• Study type: Observational

Clinical 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

Description:

1000 adult patients with locally advanced inoperable and/or metastasized PDAC undergoing first line chemotherapy

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 chemotherapy

• 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

Related Conditions & MeSH terms

• Adenocarcinoma
• Advanced Pancreatic Carcinoma
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• all approved chemotherapeutic agents from second line
all approved chemotherapeutic agents from second line

Locations

Country	Name	City	State
Austria	Medical University Graz Department of Oncology	Graz	Styria

Sponsors (5)

Lead Sponsor	Collaborator
Medical University of Graz	Krankenhaus Barmherzige Schwestern Linz, LKH Klagenfurt, Medical University Innsbruck, Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To identify prognostic and predictive features for treatment efficacy		24 months
Secondary	To identify prognostic and predictive features for clinical outcome		24 months
Secondary	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
Secondary	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
Secondary	To identify prognostic and predictive features for Thrombocytopenia	Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented	24 months
Secondary	To identify prognostic and predictive features for Anemia	Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented	24 months
Secondary	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
Secondary	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
Secondary	To identify prognostic and predictive features for rash	Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented	24 months
Secondary	To identify prognostic and predictive features for mucositis	Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented	24 months
Secondary	To identify prognostic and predictive features for Fatigue	Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented	24 months
Secondary	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
Secondary	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
Secondary	To investigate the effect of dose density on treatment efficacy of first- and second line therapy		24 months
Secondary	To investigate the effect of dose modifications on treatment efficacy of first- and second line therapy		24 months
Secondary	To perform a comparative effectiveness analysis of different palliative second line chemotherapy regimens		24 months
Secondary	To evaluate treatment behaviours after progression on palliative second line therapy		24 months
Secondary	To analyse efficacy of palliative third line therapy		24 months
Secondary	To analyse patterns of BRCA testing in real-world practice		24 months
Secondary	To analyse the impact of BRCA testing in real-world practice on treatment decisions		24 months
Secondary	To analyse the impact of BRCA testing in real-world practice on outcome		24 months
Secondary	Prevalence of primary tumor resection in patients with metastatic or locally advanced inoperable pancreatic cancer		24 months
Secondary	Prevalence of metastasectomy in patients with metastatic or locally advanced inoperable pancreatic cancer		24 months
Secondary	To evaluate the impact of primary tumor resection on outcome		24 months
Secondary	To evaluate the impact of metastasectomy on outcome		24 months
Secondary	To evaluate the impact of primary granulocyte-colony stimulating factor (G-CSF) use on dose density of FOLFIRINOX		24 months
Secondary	To evaluate the impact of primary granulocyte-colony stimulating factor (G-CSF) use on rate of febrile neutropenia		24 months
Secondary	To evaluate the impact of primary granulocyte-colony stimulating factor (G-CSF) use on overall outcome		24 months
Secondary	To evaluate patterns of molecular profiling in the real world treatment practice of advanced pancreatic cancer		24 months
Secondary	To evaluate patterns of next generation sequencing (NGS) in the real world treatment practice of advanced pancreatic cancer		24 months
Secondary	To analyse treatment patterns and outcome in the subgroup of very young (<40 years old) patients with advanced pancreatic cancer		24 months
Secondary	To analyse treatment patterns and outcome in the subgroup of very old (>75 years old) patients with advanced pancreatic cancer		24 months
Secondary	To investigate the impact of diabetes mellitus on treatment efficacy of palliative chemotherapy and disease outcome		24 months
Secondary	To investigate the impact of antidiabetic therapy on treatment efficacy of palliative chemotherapy and disease outcome		24 months
Secondary	To analyze the mutational landscape of advanced pancreatic cancer and its impact on treatment decision making and clinical outcome		24 months