This is a multicentre open labelled phase III adjuvant trial of disease-free survival in patients with resected pancreatic ductal adenocarcinoma randomized to allocation of oxaliplatin- or gemcitabine-based chemotherapy by standard clinical criteria (control arm) or by a transcriptomic treatment specific stratification signature or TSS (test arm).
The main purpose and primary objective of the study is to determine whether disease free survival in patients with resected pancreatic ductal adenocarcinoma (PDAC) treated with standard adjuvant chemotherapy regimens (oxaliplatin- or gemcitabine-based), is superior using allocation based on a treatment specific signature (TSS), compared to the same chemotherapy regimens allocated according to standard clinical criteria. Secondary objectives of the study are to assess overall survival (median, 3 year survival rate), metastasis free survival; survival based on targeted signatures (TSS) in test versus control arms, and survival using targeted therapies initially on relapse compared to standard first-line therapies on relapse. In addition, ESPAC-6 optional translational research programme will obtain tumor specimens and blodd samples to identify biomarkers that may predict response to chemotherapy or relapse. ESPAC-6 will also generate a biobank of matched patient-derived organoids (PDOs) to provide an experimentally tractable model system for the development and testing of biomarker-driven personalised therapies. ESPAC-6 translational research programme, will also develop a longitudinal blood biobank to analyse clinically relevant circulating biomarkers, such as blood proteins, metabolites and/or circulating-free tumour DNA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
394
85 mg/m2 D1 over 2 hours every; 14 days, 12 cycles, 24 weeks
150 mg/m2 D1 over 90 minutes to begin 30 min after the Folinic acid infusion is started; every 14 days, 12 cycles, 24 weeks
400 mg/m2 (racemic mixture) (or 200 mg/m2 if L-folinic acid is used), IV infusion over 2 hours; every 14 days, 12 cycles, 24 weeks
2.4 g/m2 IV continuous infusion over 46 hours (1200 mg/m2/ day); every 14 days, 12 cycles, 24 weeks
1000mg/m2 is given as an IV infusion over 30 minutes; on day 1, 8 and 15 out of 28 days (= 1 cycle); Repeated 6 times (i.e., 6 cycles) for 24 weeks
1660mg/m2/day in two divided doses administered orally for 21 days followed by 7 days' rest (one cycle) for six cycles i.e. 24 weeks
Universitätsklinikum Aachen, Studienzentrum Viszeralmedizin Klinik für Allgemeine-, Viszeral und Transplatationschirurgie
Aachen, Germany
NOT_YET_RECRUITINGUniversitätsklinikum Augsburg, III. medizinische Klinik
Augsburg, Germany
NOT_YET_RECRUITINGSt. Josef-Hospital, Klinikum der Ruhr-Universität Bochum, Abteilung für Hämatologie, Onkologie und Palliativmedizin, Studienambulanz
Bochum, Germany
NOT_YET_RECRUITINGUniversitätsklinikum Bonn, Chirurgische Abteilung
Bonn, Germany
Disease free survival
Disease free survival will be defined as time from ramdomisation to disease recurrence (growth or metastasis) or death from any cause all patients fulfilling the in- and exclusion criteria.
Time frame: 76 months
Overall survival
Overall survival is defined as the time from randomization to death due to any cause. If a patient is lost to follow up, overall survival time is censored at the time of last contact.
Time frame: 76 months
Metastasis free survival
Metastasis free survival is defined as the time from randomization to detection of metastasis or death from any cause. The time of metastasis is defined as the date of metastasis determined and recorded by the Pancreas Tumour Board (Multidisciplinary Team). If the patient is eligible for first line therapy the recurrence must be performed by a positive biopsy or cytology. If a patient is lost to follow up, metastasis free survival time is censored at the time of last contact.
Time frame: 76 months
Overall survival from recurrence
Overall survival is defined as the time from recurrence to death due to any cause. If a patient is lost to follow up, overall survival time is censored at the time of last contact.
Time frame: 76 months
Quality of life (QoL EORTC QLQ-C-30)
QoL will be assessed by the EORTC QLQ-C30 questionnaire in its most current version every three months starting from V1.
Time frame: 76 months
Safety: (serious) adverse events and Grade 3 and 4 toxicities according to NCI-CTC v.5.0.
Safety assessments will include adverse events. The proportion of grade 3 and 4 toxicity will be compared across treatments using time to event methods and frequency counts. Adverse and serious adverse events are collected throughout the study and will be tabulated and compared between study arms. The analysis of all safety endpoints is conducted on the safety set, which contains all patients who received at least one cycle of treatment.
Time frame: 47 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
DIK Deggendorf, Onkologische Ambulanz
Deggendorf, Germany
NOT_YET_RECRUITINGUniversitätsklinikum Carl Gustav Carus an der TU Dresden, Klinik und Poliklinik für Viszeral-, Thorax- und Gefäßchirurgie
Dresden, Germany
NOT_YET_RECRUITINGUniversitätsklinikum Erlangen, Chirurgische Klinik Zentrum für klinische Studien
Erlangen, Germany
NOT_YET_RECRUITINGUniversitätsklinikum Frankfurt, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie,
Frankfurt, Germany
NOT_YET_RECRUITINGUniversitätsklinikum Freiburg, Klinik für Allgemein und Viszeralchirurgie, Abteilung Chirurgie
Freiburg im Breisgau, Germany
NOT_YET_RECRUITINGUniversitätsklinikum Halle (Saale), Klinik und Poliklinik für Innere Medizin I
Halle, Germany
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