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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05526443
Other study ID # ADPACA
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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