Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2025-12-24 @ 11:52 AM
NCT ID:
NCT03825861
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03825861
Study Brief:
Protocol Section:
NCT03825861