Methods / Design
ADVERSE EVENTS, DISEASE
The RAMIRIS trial is a randomized, open-label, multicenter phase II/III study comparing treatment of FOLFIRI-Ram (arm A) with paclitaxel and ramucirumab (arm B) in patients with GEA after prior taxane containing therapy. The study will evaluate the safety and efficacy of the treatment regimens including quality of life.A total number of 318 patients will be recruited, from which 159 patients will be randomized in arm A (FOLFIRI-Ram) and 159 will be treated with paclitaxel and ramucirumab (arm B) (Fig. Study design of the RAMIRIS Phase III TrialThe protocol has been approved by the individual institutional ethics committees. All patients provided written informed consent prior to study participation.The primary endpoint of the phase III trial is to compare OS in patients with locally advanced and inoperable or metastatic GEA receiving FOLFIRI-Ram versus paclitaxel and ramucirumab as second-line therapy and who failed prior taxane-containing therapy in the intent to treat population (ITT).Secondary endpoints are to compare the disease control Rate and the PFS as well as the quality of life between the two treatment arms. The safety and tolerability of ramucirumab and FOLFIRI or paclitaxel are evaluated by monitoring the incidence, frequency and severity of adverse events (AE) according to NCI-CTCAE V 4.03 [