Instituto do Câncer do Estado de São Paulo
São Paulo, 01246-000, Brazil
Location status: Recruiting
NCT Number: NCT03825861
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 2
São Paulo, 01246-000, Brazil
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oxaliplatin 85mg/m2, Leucovorin 200mg/m2, Irinotecan 180mg/m2, 5-FU 400mg/m2 bolus followed by 2400mg/m2 continuous infusion.
Time frame: 4-8 weeks after neoadjuvant chemotherapy complete
To evaluate the Pathologic Complete Response (pCR).
Time frame: At 2, 3 and 5 years after preoperative treatment with FOLFIRINOX regimen.
Evaluate Disease-free survival (DFS).
Time frame: At 2, 3 and 5 years after preoperative treatment with FOLFIRINOX regimen.
Evaluate Overall survival (OS).
Time frame: 4-8 weeks after neoadjuvant chemotherapy complete
Evaluate the R0 resection rate (absence of microscopic residual disease).
Time frame: 4-8 weeks after neoadjuvant chemotherapy complete
Evaluate the rate of completion of treatment (chemotherapy and surgical approach).
Time frame: Through neoadjuvant chemotherapy (4 months)
Rate and description of adverse events
Time frame: Through neoadjuvant chemotherapy (4 months)
Evaluate the rate of disease progression.
Contact information is provided by the study sponsor or research team.
Instituto do Cancer do Estado de São Paulo
Other
Acronym: FOLFIRINOX
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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