Last updated 4 years ago
Neoadjuvant FOLFIRINOX in the Treatment of Locally Advanced Gastric Cancer
27 patients around the world
Available in Brazil
Instituto do Cancer do Estado de São Paulo
1Research sites
27Patients around the world
This study is for people with
Gastric cancer
Requirements for the patient
To 75 Years
All Gender
Medical requirements
- 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
- Active neoplasm of another primary site other than non-melanoma skin carcinoma.Lesions of the esophagogastric transitionUnresectable 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.
Sites
Instituto do Cancer do Estado de Sao Paulo
Recruiting
StudyFOLFIRINOX
SponsorInstituto do Cancer do Estado de São Paulo
Study typeInterventional
Conditions
Gastric cancer
Requirements
To 75 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT03825861
