A randomized phase II/III trial of conventional paclitaxel and carboplatin (cTC) versus dose-dense paclitaxel and carboplatin (ddTC), with or without bevacizumab (Bmab), for stage IVb, recurrent, or persistent cervical cancer (CC): Japan Clinical Oncology Group study (JCOG1311).

TPS5603Background: Patients with metastatic or recurrent CC who are not amenable to curative treatment with surgery or radiation have a poor prognosis, and systemic chemotherapy is regarded as a standard treatment. Based on the JCOG0505, we considered tri-weekly cTC as the standard regimen. We subsequently focused on dose-dense, weekly administered paclitaxel, which was more effective than conventional administration for breast cancer and, in Japan, ovarian cancer. The efficacy and safety of ddTC have not been evaluated for CC. Therefore, we designed JCOG1311 to confirm the superiority of ddTC to cTC in metastatic or recurrent CC. However, Bmab was approved in Japan for treatment of metastatic or recurrent CC on May 2016. We amended the protocol to add the criteria by which patients would receive Bmab. Methods: Major eligibility criteria are stage IVB, persistent, or recurrent CC patients including SCC or adenocarcinoma histology. We enroll patients according to institution, PS, and platinum-free interval...