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Copyright ©The Author(s) 2018.
World J Gastrointest Oncol. Sep 15, 2018; 10(9): 271-281
Published online Sep 15, 2018. doi: 10.4251/wjgo.v10.i9.271
Table 3 The main phase I/II trials in gastric cancer that evaluate the preoperative therapy
TrialYear/typeN° of patientsTreatment scheduleMedian FUSevere toxicityClinical efficacySurvivalLimits/characteristics
Matsuda[51]2014/ Phase I9SP q15 + RTNRDiarrhea (11.1) Anorexia (11.1)PR (78) SD (22)NRMTD: CDDP 25 mg/m2
Michel[37]2014/ Phase II42FOLFIRIx4→CRT38.1 moDuring FOLFIRI (26.2) During RT (19.1)CR (8.6) Median PFS: 12.3 moMedian OS: 26.4 moReduced feasibility, 73.8% of patients completed the schedule
Trip[38]2014/ Phase I/II25CBDCA-PTX + RTNRNausea (4) Anorexia (4) Esophagitis (4) Leukopenia (12) Febrile neutropenia (4) Thrombosis (4) Fatigue (4)CR (16) PR (52)Median OS: 15 mo
Wydmanski[40]2014/ Phase II135FU + RT30.1 moNausea (7.7) Vomiting (7.7) Thrombocytopenia (92.3) Leukopenia (7.7)NRMedian OS: 17.1 mo 3-yr OS: 48%Inoperable patients. High rate of severe thrombocytopenia, with 5FU 325 mg/m2 d1-5 and 29-33
Liu[52]2017/ Phase II40SOXx1→S-1 + RT → SOXx1 → surgery→SOXx426.5 moLeukopenia (10) Neutropenia (10) Thrombocytopenia (2.5)CR (7.5) PR (30) SD (40) PD (12.5) 2-yr DFS: 47%2-yr OS: 56%Treatment compliance: 87.5%