Study rationale
NCT03081143, neurotoxic
RECURRENCE
Current treatment algorithms recommend a taxane- containing triplet regimen for selected patients as first-line therapy for advanced GEA [Recurrence rates for initially curative treated patients remain high, ranging between 36% to about 70% for patients who received a taxane containing perioperative regimen [As a significant number of patients with GEA suffer from neurotoxic side-effects after first-line treatment with FOLFOX (30–70%) a second line treatment containing a taxane is less reasonable for this group [The safety analysis of the phase II RAMIRIS trial did not reveal any unexpected safety issues. The results of the safety interim analysis provide further support for the safety and efficacy of second-line FOLFIRI-Ram in this patient group [Therefore, the Arbeitsgemeinschaft Internistische Onkologie (AIO) investigators implemented a phase III portion of the RAMIRIS phase II trial, which is currently ongoing (NCT03081143). The phase III portion will not utilize the patients enrolled into the phase II portion.The phase III portion of the RAMIRIS trial will evaluate whether the combination of FOLFIRI-Ram (investigational arm A) is superior in terms of OS and ORR compared to the standard treatment of ramucirumab plus paclitaxel (control arm B) in patients who had received a taxane (docetaxel or paclitaxel). This might lead to a new standard of care in this particular group of patients by changing the national and international guidelines.