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 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT04047004
Eligibility Criteria:
Inclusion Criteria:
* Patients with high-risk GAC defined as: Diffuse cancer (signet ring cells predominant) or clinical stage: cTany + cN2-3 or cT3-T4 + cNany or GAC patients with preoperative positive peritoneal cytology submitted to laparoscopic gastrectomy (+/- neoadjuvant treatment).
* Age 18 or above
* Written informed consent
* Women must be postmenopausal or use adequate contraception with a negative pregnancy test at inclusion.
Exclusion Criteria:
* Previous allergic reaction to cisplatin, doxorubicin or other platinum containing compounds.
* Renal impairment, defined as GFR \< 40 ml/min (Cockcroft-Gault Equation).
* Myocardial insufficiency, defined as NYHA class 3-4.
* Impaired liver function defined as bilirubin ≥ 1.5 x UNL (upper normal limit).
* Inadequate haematological function defined as absolute neutrophil count (ANC) ≤ 1.5 x 10\^9/l and platelets ≤ 100 x 10\^9/l.
* Any other condition or therapy, which in the investigator's opinion may pose a risk to the patient or interfere with the study objectives.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04047004
Study Brief:
Protocol Section:
NCT04047004