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Table 2 Inclusion and exclusion criteria

From: A multicenter phase 4 geriatric assessment directed trial to evaluate gemcitabine +/− nab-paclitaxel in elderly pancreatic cancer patients (GrantPax)

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. +