Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2025-12-24 @ 3:00 PM
NCT ID:
NCT02707159
Eligibility Criteria:
Inclusion Criteria:
* Male or female \> 18 years up to 80 years
* Histologically or cytologically proven adenocarcinoma of the pancreas before start of treatment. Also patients for whom there is a strong suspicion of unresectable pancreatic cancer will before the diagnosis is confirmed be asked for consent to take 2 additional biopsies at the time of diagnostic biopsy retrieval, in case the histological analysis confirms that they can be included.
* Locally advanced (primarily unresectable) and/or metastatic disease.
* Presence of at least one measurable lesion according to the RECIST criteria, not restricted to previously irradiated area or limited to bone, pleural effusion or ascites.
* ECOG/WHO performance status ≤2
* Absolute neutrophil count (ANC) \>1.5 x 109 /L and platelet count \>100 x 109/L
* Total bilirubin \< 1.5 times the upper limit of the normal range at the institution (ULN) or AST or ALT \< 2 x ULN. If liver metastases are present, patients can be included if total bilirubin \< 5× ULN or AST/ALT \<10× ULN. Dose reductions of paclitaxel will be performed when bilirubin \>2xULN, depending on increase of the bilirubin level according to the recommendations of the Summary of Product Characteristics.
* Serum creatinin \< 1,5 ULN / calculated creatine clearance \> 60 ml/min.
* Written informed consent
Exclusion Criteria:
* Current infection, bowel obstruction or subobstruction, or other uncontrolled intercurrent illness.
* Prior medical treatment for advanced pancreatic cancer
* Confirmed brain metastasis.
* Concurrent or past history of another malignancy except curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix.
* Treatment with any other investigational drug more than 30 days prior to study entry.
* Allergy to anyone of the included drugs.
* Female patient breast feeding or pregnancy
* Not able/ or not willing to use adequate contraception (defined below). A pregnancy test will be included in the baseline visit for women of childbearing potential.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02707159
Study Brief:
Protocol Section:
NCT02707159