Extending Outcomes for Pancreas Cancer Patients With Nominal Oligometastatic Disease (EXPAND): A Randomized Phase III Trial

Inclusion Criteria: Age 18 Histologically or cytologically confirmed pancreatic ductal adenocarcinoma. Histologic / cytologic confirmation of pancreatic ductal adenocarcinoma may come from the primary tumor (i.e., via FNA at initial diagnosis). Histological/pathologic confirmation of distant metastatic disease is not required if clinical and radiographic consensus is that the patient has distant metastatic disease. Eastern Cooperative Oncology Group (ECOG) performance status ≤2 Candidate for MDT (including radiation therapy, surgical resection, ablation, and embolization) to all sites of disease including oligometastatic sites and if present intact primary / regional nodal disease. Between one and five distant metastatic lesions, counted as follows: each lesion (not site) will be counted as one, with the exception of metastatic lymph node stations, which will collectively count as one lesion. Regional nodal stations will be counted as a collective single lesion if present. All progressive lesions must be amenable to local therapy as noted in criterion 4.2.1.4 above. Counting of oligometastatic nodal disease will be based on nodal chains. A nodal chain will be considered a single metastatic lesion if the presence of that node results in the patient as having M1 disease per the TNM staging system, AJCC version 8.0. In addition, one of the following criteria must be met: a) ≥1 LN meets radiologic criteria for metastatic disease via RECIST 1.1 (short axis ≥15mm), b) pathol…