Table 2 Inclusion and exclusion criteria
GOGO and SLOWGO Arms | NOGO Arm | |
|---|---|---|
Inclusion criteria | ||
Patients ≥70 years of age | + | + |
Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. | + | + |
No prior chemotherapy (except fluoruracil or gemcitabine in an adjuvant setting at least > 6 months prior enrollment). | + | + |
Cooperation and willingness to complete all aspects of the study | + | + |
Written informed consent to participate in the study | + | + |
At least one measurable lesion of disease according to RECIST 1.1 criteria. | + | |
Adequate end organ function (renal function: serum creatinine ≤1.5 × ULN or GFR≥30mL/min, hematopoietic function: white blood cell (WBC) count ≥3000/μL, absolute neutrophil count (ANC)≥1500/μL, platelets ≥105/μL, hemoglobin level>9.0g/dL, liver function: total bilirubin ≤1.5 × ULN, AST / ALT ≤3.0 × ULN) | + | |
Exclusion criteria | ||
Patient has received any other investigational product within 28days prior study entry | + | + |
Patient is < 5years free of another primary malignancy (except: not currently clinically significant nor requiring active intervention) | + | + |
Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent | + | + |
Any psychiatric illness that would affect the patient’s ability to understand the demands of the clinical trial | + | + |
Parallel participation in another clinical trial or participation in another clinical trial within the last 30days or 7 half-lifes of a study medication, whichever is of longer duration, prior study start | + | + |
Patient has a severe and/or uncontrolled medical disease (i.e. uncontrolled active infection, uncontrolled hypertension/ diabetes or cardiac disease). | + | |
Hypersensitivity against gemcitabine or nab-paclitaxel. | + | |
Major surgery ≤28 days prior to study entry. | + | |
Patient has a known diagnosis of human immunodeficiency virus (HIV) infection. | + | |