Surgery Clinical Trial
Official title:
A Phase II Study of Neoadjuvant Chemotherapy With Modified FOLFOX6 Regimen and Effects of Tumor Regression in Locally Advanced Gastric Cancer
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.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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