Randomized controlled phase III study comparing chemotherapy alone versus conversion surgery after a remarkable response to chemotherapy in patients with initially unresectable cStage IVB or pStage IV gastric cancer (JCOG2301, Conversion study)

The standard approach for stage IV gastric cancer is palliative chemotherapy. However, despite the advancements in various chemotherapy regimens, the prognosis remains poor, highlighting the urgent need to develop more effective treatment strategies. The controversy persists regarding the integration of a local therapy including surgery in the management of unresectable stage IV gastric cancer. This randomized phase III trial aims to confirm the additional benefit of conversion surgery following palliative chemotherapy compared with palliative chemotherapy alone with respect to overall survival in patients initially diagnosed with unresectable clinical stage IVB or pathological stage IV gastric cancer after a remarkable response to chemotherapy. This study plans to enroll 126 patients from 63 institutions in Japan for 5 years, and it has been registered in the Japan Registry of Clinical Trials as jRCTs031240340 (https://jrct.niph.go.jp/latest-detail/jRCTs031240340).