FOLFOX6 as Neoadjuvant Chemotherapy in Local Advanced Gastric Cancer
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Purpose: This aim of the study is to evaluate the efficacy and safety of neoadjuvant
chemotherapy with the modified FOLFOX6(mFOLFOX6) regimen and its impact on survival on a
series in local advanced gastric cancer patients.
Patients and methods: The study is a prospective non-randomized study. Patients with
histopathologically confirmed and locally advanced gastric cancer(T2-T4 or N+) are enrolled
in the study. Patients are given mFOLFOX6 scheme for 3 cycles.A radical gastrectomy and a D2
lymphadenectomy was will be scheduled 3-6 weeks after the completion of the preoperative
chemotherapy. Down-staging is assessed comparing pretreatment clinical staging with
postoperative pathologic staging on patients who underwent radical surgery. Tumor
down-staging and the grade of pathologic response are included in a statistical correlation
between tumor regression induced by mFOLFOX6 neoadjuvant chemotherapy and survival.The
primary endpoint is 3-year overall survival, secondary endpoints are disease-free survival,
R0 resection rate, toxicity and prediction of response.