Neoadjuvant FOLFIRINOX in the Treatment of Locally Advanced Gastric Cancer
Status:
Recruiting
Trial end date:
2026-12-30
Target enrollment:
Participant gender:
Summary
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.