Surgery plus chemotherapy versus chemotherapy alone for pancreatic cancer that has spread

Who can take part

• Age ≥ 18 years and ≤ 80 years
• histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas
• medical and technical operability of the primary tumor
• limited synchronous liver metastatic status (≤3 resectable/ablatively treatable liver metastases) OR limited metachronous liver metastatic status (≤3 resectable/ ablatively treatable liver metastases), but must have completed adjuvant chemotherapy at least 6 months before start of study treatment
• Previous neo-/adjuvant anti-cancer therapy for non-metastatic PDAC with last dose administered ≥6 months before the start of study treatment are allowed
• adequate hematological (WBC ≥3000/µl, platelets ≥100.000/µl, hemoglobin ≥8 g/dl), hepatic (bilirubin ≤2.5 x mg/dl) and renal function (creatinine clearance >50 ml/min) parameters
• ECOG performance status ≤1
• Written informed consent obtained according to international guidelines and local laws
• measurable disease according to RECIST v1.1. prior to induction therapy

Who cannot take part

• Prior chemotherapy within 6 months or prior radiation therapy within 28 days (e.g. in adjuvant settings). Exception for previous systemic anti-cancer treatment for metastatic PDAC: Patients with need of immediate treatment (high tumour load, symptoms) may have received one cycle of FOLFIRINOX or modified FOLFIRINOX prior to study entry (Cycle 0) and may be enrolled after Coordinating Investigator approval has been obtained
• Concurrent malignancy other than the disease under investigation with exception of malignancy that was treated curatively and has not recurred within 2 years prior to the date of screening. Fully resected basal or squamous cell skin cancers and any carcinoma in situ are eligible
• Impaired cardiac function or clinically significant cardio-vascular disease, such as: – Congestive heart failure requiring treatment (NYHA grade >2), or clinically significant arrhythmia (including uncontrolled atrial flutter/fibrillation) – Acute myocardial infarction, unstable angina pectoris, coronary stenting, or bypass surgery < 3 months prior to study entry
• Unresectable pancreatic cancer
• Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. These conditions should be discussed with the patient before registration in the trial
• Known hypersensitivity to the active substances or any of the excipients
• Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly)
• Patients with either peritoneal carcinomatosis or >3 liver metastases or extrahepatic metastasis)
• Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed
• Inability to understand the study and/or comply with the protocol procedures
• Subject pregnant or breast feeding, or planning to become pregnant within 6 months