Study population and eligibility criteria
toxicity, liver and kidney function, non-resectable, Cancer
ADVERSE EVENT, RECURRENCE, DISEASE, ADENOCARCINOMA OF THE PANCREAS, CANCER
Patients are recruited from six of seven oncological departments treating patients with PC in Denmark, covering 85% of the oncological PC population [A full description of eligibility criteria is provided elsewhere (NCT05841420). Briefly, all patients included are at least 18 years of age with non-resectable, pathologically verified adenocarcinoma of the pancreas, not candidate for full dose combination chemotherapy but eligible for standard dose gemcitabine. Patients are in ECOG PS ≤ 2, with measurable or non-measurable disease, having adequate hematologic, liver and kidney function, and with toxicity of possible prior adjuvant chemotherapy resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) ver.5.0 < grade 2 [Main exclusion criteria are eligibility for downstaging/preoperative chemotherapy, prior chemotherapy for PC except adjuvant therapy with recurrence occurring more than 6 months after end of treatment, and other conditions or therapy, which in the investigator’s opinion may pose a risk to the patient or interfere with the study objectives.The intention-to-treat (ITT) population includes all randomized patients. The per protocol (PP) population includes all randomized patients who receive at least one dose of planned chemotherapy and will be the population for all safety analyses.