OncoMatch/Clinical Trials/NCT03825861
Neoadjuvant FOLFIRINOX in the Treatment of Locally Advanced Gastric Cancer
Is NCT03825861 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies FOLFIRINOX for gastric cancer.
Treatment: FOLFIRINOX — Phase II single-arm study designed to evaluate the efficacy and safety of preoperative chemotherapy with FOLFIRINOX regimen. The investigators will include 27 patients with resectable locally advanced gastric cancer. They will receive preoperative chemotherapy with FOLFIRINOX regimen by long-term catheter every 14 days for 8 cycles accounting for a total of 4 months of systemic treatment. In the period between 4 and 8 weeks of the last cycle, restaging tests will be performed and if there is no metastatic progression of disease, the patient will undergo surgical treatment with curative intention. The objective is to evaluate whether preoperative treatment with FOLFIRINOX regimen involving continuous infusion and bolus infusion of 5-fluoruracil, irinotecan bolus and oxaliplatin bolus is effective and safe in the neoadjuvant treatment of locally advanced gastric cancer. The planned recruitment period is 48 months (4 years). There will be a total of 4 months of preoperative chemotherapy. In case of limiting toxicity or disease progression, chemotherapy will be suspended and patients may undergo resection of the primary neoplasia at the discretion of the surgical team of the institution. Patients will be followed for 5 years after entry of the last participant in the protocol for OS and PFS evaluation. The end of the study will occur when the last participant completes their last follow-up visit, which should occur no later than 60 months after enrollment in the study.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Cannot have received: radiation therapy
Lab requirements
Kidney function
creatinine clearance greater than 50 mL / min required
Liver function
Total bilirubin above 1.5mg / dL excluded; hepatic transaminases greater than 1.5 times the upper limit of normality excluded
Cardiac function
Decompensated and / or symptomatic cardiomyopathy: congestive heart failure with functional class greater than 2 by the New York Heart Association; active coronary disease; uncontrolled cardiac arrhythmia; history of acute myocardial infarction in the last 6 months [excluded]
Preserved renal function (creatinine clearance greater than 50 mL / min). Total bilirubin above 1.5mg / dL [excluded]. Hepatic transaminases greater than 1.5 times the upper limit of normality [excluded]. Decompensated and / or symptomatic cardiomyopathy: congestive heart failure with functional class greater than 2 by the New York Heart Association; active coronary disease; uncontrolled cardiac arrhythmia; history of acute myocardial infarction in the last 6 months [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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