- For patients with locally advanced disease, no previous radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of PDAC is permitted. For patients with metastatic disease, prior treatment for non-metastatic disease with 5-FU or gemictabine administered as radiation sensitizer, or as a cytotoxic therapy, in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no ≥ Grade 2 treatment-related toxicities are present.