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:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT06295094
Eligibility Criteria:
Inclusion criteria
* Gastric or Gastroesophageal junction Siewert type III adenocarcinomas
* Clinical T3-4a-stages
1. Any differentiation grade
2. Any histological subtype
* Clinical T2-stage
a. If poorly differentiated or of the poorly cohesive histological subtype, with or without the presence of signet-ring cells
* Any clinical T-stage with positivity for malignant cells on abdominal lavage cytology, which is converted to cytology negative in response to neoadjuvant chemotherapy.
* Any clinical nodal-stage
* clinical M0-stage (positive abdominal wash cytology, which is converted to cytology negative in response to neoadjuvant therapy, is permitted)
* Performance status Eastern Cooperative Oncology Group (ECOG) 0-1
* Age 18 - 80 years
* Undergoing robotic or laparoscopic D2 gastrectomy
* Able and willing to provide written informed consent and to comply with the clinical study protocol
* Fertile women must have a negative pregnancy test at the time of inclusion and must use adequate contraception.
Exclusion criteria
* Previous allergic reaction to cisplatin, doxorubicin or other platinum-containing compounds.
* Renal impairment, defined as glomerular filtration rate (GFR) \< 40 ml/min (Cockcroft-Gault Equation).
* Myocardial insufficiency, defined as New York Heart Association (NYHA) class 3-4.
* An impaired liver function, defined as bilirubin ≥ 1.5 x upper normal limit (UNL).
* An inadequate haematological function, defined as absolute neutrophil count (ANC) \<1.5 x 109/l and platelets \<100 x 109/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
Maximum Age:
80 Years
Study:
NCT06295094
Study Brief:
Protocol Section:
NCT06295094