Tsuburaya 2012.
Trial name or title | A randomized phase II trial to elucidate the efficacy of capecitabine plus cisplatin (XP) and S‐1 plus cisplatin (SP) as a first‐line treatment for advanced gastric cancer: XP ascertainment vs. SP randomized PII trial (XParTS II) |
Methods | Multicentre RCT 2 arms |
Participants | N = 100 (planned) |
Interventions | Arm A: S‐1 (40 mg/m² twice a day d1‐21) + cisplatin (60 mg/m² d 8) repeated at d 35 versus Arm B: capecitabine (1000 mg/² d1‐14) + cisplatin (80 mg/m² d 1) repeated at d 21 |
Outcomes | Progression‐free survival, overall survival, time to treatment failure, tumour response, safety |
Starting date | August 2011 |
Contact information | Akira Tsuburaya, Department of Gastrointestinal Surgery, Kanagawa Cancer Center, 1‐1‐2, Nakao, 241‐0815, Yokohama, Asahi‐ku, Japan, tuburayaa@kcch.jp |
Notes | The study is registered (NCT01406249), the study protocol is published. Estimated study completion date is June 2015. The study is not yet published. |
5‐FU: 5‐fluorouracil ci: continuous infusion d: day E: epirubicin G‐CSF: granulocyte colony stimulating factor PFS: progression‐free survival RCT: randomised controlled trial