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 @ 12:34 PM
Ignite Modification Date:
2025-12-24 @ 12:34 PM
NCT ID:
NCT04180761
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent of the patient
* Positive lavage cytology in staging laparoscopy
* Intraoperative R0- or R1-gastrectomy (Re-evaluation intraoperative)
* Histologically confirmed locally advanced, resectable Adenocarcinomas of the stomach (incl. AEG II-III): \>cT3 and/or cN+ and cM0 (none existing solid Peritoneal metastases, Re-evaluation intraoperative)
* Neoadjuvant chemotherapy ≥ 2 cycles
Exclusion Criteria:
* \< 18 years
* Existence of contraindications or contraindications against the study medication
* Uncompensated Heart Failure (NYHA III and IV)
* Severe CHD, medically insufficient treatable cardiac arrhythmias, uncontrolled arterial hypertension
* Serum creatinine ≥ 1.5 x the standard value or a Creatinine clearance \< 60 ml/min/1.73 m2
* Severe pulmonary dysfunction (COPD, PAH), Pulmonary function test confirmed (IVC \< 55 %, DLCO \< 40%)
* malignant secondary tumor disease that persists for \< 5 years (Exception: in situ carcinoma of the cervix, adequately treated basal cell carcinoma of the skin)
* Participation in other interventional studies that at the time of the ProPeC study inclusion, still are not finished
* pregnancy or lactation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04180761
Study Brief:
Protocol Section:
NCT04180761