Perioperative mFOLFOX-6 in Locally Advanced Gastric Cancer

Study Overview
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Brief Summary
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This is a Phase II Trial of Perioperative Chemotherapy with Oxaliplatin, 5-Fluorouracil, Leucovorin(MODIFIED FOLFOX6)in Patients with Locally Advanced Operable Gastric Cancer.

Detailed Description
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The main purpose of this study is to evaluate response rate (clinical response and pathological response) of oxaliplatin, 5-fluorouracil, leucovorin(MODIFIED FOLFOX6)

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

Conditions
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Advanced Gastric Cancer

Intervention / Treatment
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* Drug: MODIFIED FOLFOX6


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previously untreated patients with pathologically proven advanced gastric adenocarcinoma with regional LN metastasis are eligible for this study (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) [17] is required. Other eligibility criteria include age between 18 and 75 years, Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1, no prior chemotherapy or radiotherapy, and 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: Exclusion criteria include 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, and other serious diseases.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MODIFIED FOLFOX6|Modified FOLFOX6 regimen consists of oxaliplatin 100 mg/m2 and FA 100 mg/m2 given as a 2 hour intravenous infusion, followed by 5-FU 2.4 g/m2 given as a continuous infusion over 46 hour, repeated every 2 weeks. Patients receive 4 cycles of neoadjuvant modified FOLFOX6 followed by curative radical surgery with D2 dissection and 4 cycles of adjuvant modified FOLFOX6.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate | response rate by the RECIST criteria | 22 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| toxicity | toxicity : Grade 3-4 toxicity by the NCI-CTCAE v3.0 | one year | 
| median overall survival | median value of the time from enrollment to the patient's death | 1 year | 
| median time to treatment failure | median value of the time from enrollment to disease progression, withdrawl of consent, or unacceptable toxicity | 1 year | 
| resection rate | the rate of patients whose tumor was completely resected | 1 year |