Status:
RECRUITING
Neoadjuvant FOLFIRINOX in the Treatment of Locally Advanced Gastric Cancer
Lead Sponsor:
Instituto do Cancer do Estado de São Paulo
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03825861
Start Date
February 23 2017
End Date
December 30 2026
Last Update
November 10 2020
Active Locations (1)
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1
Instituto do Câncer do Estado de São Paulo
São Paulo, Brazil, 01246-000