Spots Global Cancer Trial Database for FOLFOX6 as Neoadjuvant Chemotherapy in Local Advanced Gastric Cancer

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Trial Identification

Brief Title: FOLFOX6 as Neoadjuvant Chemotherapy in Local Advanced Gastric Cancer

Official Title: A Phase II Study of Neoadjuvant Chemotherapy With Modified FOLFOX6 Regimen and Effects of Tumor Regression in Locally Advanced Gastric Cancer

Study ID: NCT02226380

Conditions

Gastric Cancer

Effects of Chemotherapy

Surgery

Interventions

mFOLFOX6 regimen

Study Description

Brief 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.

Detailed Description: