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JOURNAL ONKOLOGIE – STUDIE
ADPACA

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

Rekrutierend

NCT-Nummer:
NCT05526443

Studienbeginn:
Januar 2023

Letztes Update:
28.04.2023

Wirkstoff:
all approved chemotherapeutic agents from second line

Indikation (Clinical Trials):
Adenocarcinoma, Pancreatic Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Medical University of Graz

Collaborator:
Medical University of Vienna, Medical University Innsbruck, LKH Klagenfurt, Krankenhaus Barmherzige Schwestern Linz,

Kontakt

Studienlocations
(1 von 1)

Medical University Graz Department of Oncology
8036 Graz
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Jakob Riedl, Dr. Dr.
Phone: +43 316 385 31256
E-Mail: j.riedl@medunigraz.at

Karin Groller, MPH
Phone: +43 316 385 14174
E-Mail: karin.groller@medunigraz.at
» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

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

first line chemotherapy

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. 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:

1. To identify prognostic and predictive features for treatment efficacy (Time Frame - 24 months)

2. To identify prognostic and predictive features for clinical outcome (Time Frame - 24 months)

3. To identify prognostic and predictive features for Neuropathy (Time Frame - 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

4. To identify prognostic and predictive features for Febrile Neuropathy (Time Frame - 24 months):
Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented

5. To identify prognostic and predictive features for Thrombocytopenia (Time Frame - 24 months):
Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented

6. To identify prognostic and predictive features for Anemia (Time Frame - 24 months):
Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented

7. To identify prognostic and predictive features for Nausea/Vomiting (Time Frame - 24 months):
Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented

8. To identify prognostic and predictive features for Skin toxicity (Time Frame - 24 months):
Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented

9. To identify prognostic and predictive features for rash (Time Frame - 24 months):
Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented

10. To identify prognostic and predictive features for mucositis (Time Frame - 24 months):
Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented

11. To identify prognostic and predictive features for Fatigue (Time Frame - 24 months):
Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented

12. To identify prognostic and predictive features for Allergic reactions (Time Frame - 24 months):
Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented

13. To identify prognostic and predictive features for all other Adverse Events (Time Frame - 24 months):
Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented

14. To investigate the effect of dose density on treatment efficacy of first- and second line therapy (Time Frame - 24 months)

15. To investigate the effect of dose modifications on treatment efficacy of first- and second line therapy (Time Frame - 24 months)

16. To perform a comparative effectiveness analysis of different palliative second line chemotherapy regimens (Time Frame - 24 months)

17. To evaluate treatment behaviours after progression on palliative second line therapy (Time Frame - 24 months)

18. To analyse efficacy of palliative third line therapy (Time Frame - 24 months)

19. To analyse patterns of BRCA testing in real-world practice (Time Frame - 24 months)

20. To analyse the impact of BRCA testing in real-world practice on treatment decisions (Time Frame - 24 months)

21. To analyse the impact of BRCA testing in real-world practice on outcome (Time Frame - 24 months)

22. Prevalence of primary tumor resection in patients with metastatic or locally advanced inoperable pancreatic cancer (Time Frame - 24 months)

23. Prevalence of metastasectomy in patients with metastatic or locally advanced inoperable pancreatic cancer (Time Frame - 24 months)

24. To evaluate the impact of primary tumor resection on outcome (Time Frame - 24 months)

25. To evaluate the impact of metastasectomy on outcome (Time Frame - 24 months)

26. To evaluate the impact of primary granulocyte-colony stimulating factor (G-CSF) use on dose density of FOLFIRINOX (Time Frame - 24 months)

27. To evaluate the impact of primary granulocyte-colony stimulating factor (G-CSF) use on rate of febrile neutropenia (Time Frame - 24 months)

28. To evaluate the impact of primary granulocyte-colony stimulating factor (G-CSF) use on overall outcome (Time Frame - 24 months)

29. To evaluate patterns of molecular profiling in the real world treatment practice of advanced pancreatic cancer (Time Frame - 24 months)

30. To evaluate patterns of next generation sequencing (NGS) in the real world treatment practice of advanced pancreatic cancer (Time Frame - 24 months)

31. To analyse treatment patterns and outcome in the subgroup of very young (<40 years old) patients with advanced pancreatic cancer (Time Frame - 24 months)

32. To analyse treatment patterns and outcome in the subgroup of very old (>75 years old) patients with advanced pancreatic cancer (Time Frame - 24 months)

33. To investigate the impact of diabetes mellitus on treatment efficacy of palliative chemotherapy and disease outcome (Time Frame - 24 months)

34. To investigate the impact of antidiabetic therapy on treatment efficacy of palliative chemotherapy and disease outcome (Time Frame - 24 months)

35. To analyze the mutational landscape of advanced pancreatic cancer and its impact on treatment decision making and clinical outcome (Time Frame - 24 months)

Geprüfte Regime

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

Quelle: ClinicalTrials.gov


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