Neoadjuvant FOLFIRINOX in the Treatment of Locally Advanced Gastric Cancer

  • End date
    Dec 30, 2026
  • participants needed
  • sponsor
    Instituto do Cancer do Estado de São Paulo
Updated on 27 January 2021


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.

Condition Gastropathy, Stomach Discomfort, Gastric Cancer, Gastric Cancer, Stomach Cancer, Stomach Discomfort, Gastric Carcinoma, Stomach Cancer, gastric cancers
Clinical Study IdentifierNCT03825861
SponsorInstituto do Cancer do Estado de São Paulo
Last Modified on27 January 2021


Yes No Not Sure

Inclusion Criteria

Histological diagnosis of gastric adenocarcinoma that is amenable to surgical resection at diagnosis, with locally advanced disease criteria for clinical evaluation (T3 tumors, T4 tumors and / or regional lymph node involvement)
Absence of metastatic disease at a distance (computerized tomography, diagnostic laparoscopy and peritoneal lavage)
Age 18-75 years
Clinical functionality by the ECOG scale between 0 and 1
Preserved renal function (creatinine clearance greater than 50 mL / min)
Signature of Informed Consent Form

Exclusion Criteria

Active neoplasm of another primary site other than non-melanoma skin carcinoma
Lesions of the esophagogastric transition
Unresectable lesions by computed tomography and / or diagnostic laparoscopy
Obstructive tumors (acute intestinal occlusion or subocclusion)
Tumors with signs of significant or persistent bleeding
Carcinoma in situ
Different histological type of adenocarcinoma
Gastric stump tumors
Previous chemotherapeutic or radiotherapy treatment
Current pregnancy or breastfeeding
Total bilirubin above 1.5mg / dL
Hepatic transaminases greater than 1.5 times the upper limit of normality
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
Psychological, familial, social or even geographical condition that potentially hinders adherence to the study protocol and the pre-established follow-up
Current or previous psychiatric or neurological diagnosis that is decompensated, compromises the cognition, functionality or adherence to the proposed treatment
Other comorbidities that are decompensated at the time of treatment
Pregnant or breastfeeding women
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