Neoadjuvant Combination Chemotherapy of DCS (Cisplatin + Docetaxel + S-1) and DCF (Docetaxel + Cisplatin + 5-FU) in Patients With Locally Advanced Gastric Adenocarcinoma

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2009
Number of patients planned The study adopted two parallel phase II studies, with the same P1 and P0 in each arm, suggested by Logan. The investigators hypothesized a target ORR of interest, P1=50, and a lower ORR, P0=25 with the treatment of DCS and DCF, respectively. Under the assumption of α-error=0.05 and β-error= 0.2, using sample size tables of A\'Hern, 26 patients were required per arm to achieve the desired statistical power. Finally, taking a 20% drop-out rate into consideration, the overall number of enrolled patients was 62.
Epistemonikos ID: 8ca62ca3ceb2b793bf85c15ec05cf68e7303eec5
First added on: May 06, 2024