A Phase II Trial of Perioperative Chemotherapy With Oxaliplatin, 5-Fluorouracil, Leucovorin(MODIFIED FOLFOX6) in Patients With Locally Advanced Operable Gastric Cancer

The role of perioperative chemotherapy in potentially operable advanced gastric cancer (AGC) with regional lymph node metastasis is still in the area of controversy. The aim of this study is to evaluate the efficacy and toxicity of folinic acid (FA), infusional 5-fluorouracil (5-FU), and oxaliplatin (modified FOLFOX6) in potentially resectable AGC with regional lymph node (LN) metastasis.

Inclusion Criteria:

• Previously untreated patients with pathologically proven advanced gastric adenocarcinoma with regional LN metastasis (clinical stage: cT2-4 and N+)
• At least one measurable regional lymph node metastasis according to the Response Evaluation Criteria in Solid Tumors (RECIST v. 1.0)
• age between 18 and 75 years
• Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
• no prior chemotherapy or radiotherapy
• adequate bone marrow, hepatic and renal function (absolute neutrophil count [ANC] ≥ 1.5ⅹ109/L, platelet count ≥ 100ⅹ109/L, total bilirubin ≤ 1.5ⅹupper limit of normal [ULN], serum transaminases ≤ 2.5ⅹULN, alkaline phosphatase ≤ 2.5ⅹULN, serum creatinine ≤ 1.5ⅹULN or actual or calculated creatinine clearance ≥ 50 mL/min).

Exclusion Criteria:

• clinical stage T1 tumors
• clinical or radiologic evidence of distant metastasis
• intestinal obstruction or impending obstruction
• active tumor bleeding
• interstitial pneumonitis or symptomatic pulmonary fibrosis
• peripheral neuropathy of National Cancer Institute Common Toxicity Criteria (NCI-CTC) grade ≥1
• pregnant or breastfeeding patients
• other serious diseases