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 @ 3:02 AM
Ignite Modification Date:
2025-12-25 @ 3:02 AM
NCT ID:
NCT01882933
Eligibility Criteria:
Inclusion Criteria:
* 18 \< age ≤ 75 years old
* White blood cells \> 3,500/mm3, neutrophils ≥ 1,500/mm3, platelets ≥ 100,000/mm3
* Good renal functions, serum creatinine values being \< 1.5 mg/dl and creatinine clearance \> 60 ml/min
* Performance Status ≤1, Karnofsky Index ≥ 70%
* Serum bilirubin ≤ 2 mg/dl
* Having given written informed consent prior to any procedure related to the study.
* Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research
* Not under any administrative or legal supervision
* Histologically evidenced resectable T3 or T4 gastric adenocarcinoma for which a curative gastrectomy is scheduled, with invasion into the serosa AND/OR lymph node metastasis (determined from data obtained by endoscopic ultrasound and chest, abdomen and pelvis CT scan) AND/OR positive peritoneal cytology (sampled during the preoperative laparoscopy).
AND/OR
* Perforated gastric adenocarcinoma AND/OR
* Siewert III adenocarcinoma of the cardia for which a gastrectomy by exclusive abdominal laparotomy is scheduled
* Females of childbearing age potential and male subjects with partners of childbearing potential using efficient contraceptive measures (as judged by the investigator).Subjects randomised in the arm with HIPEC should be informed and accept that these requirements should also extend to :
* 4 months after the treatment with Oxaliplatin for female subjects,
* 6 months after the treatment with Oxaliplatin for male subjects.
Exclusion Criteria:
* Prior malignant tumors with detectable signs of recurrence
* Gastric stump adenocarcinoma
* Presence of comorbidities, notably serious chronic diseases or organ failure General conditions
* Any subject in exclusion period of a previous study according to applicable regulations
* Pregnancy or breastfeeding
* Females of childbearing age potential or male subjects with partners of childbearing potential not using medically accepted contraceptive measures, as judged by the investigator Interfering substance
* Contraindication to any drug contained in the chemotherapy regimen Specific to the study
* Life threatening toxicity before surgery
* Distant metastases (liver, lung. ovaries, etc)
* Tumoral infiltration of the head or body of the pancreas
* Patients presenting an adenocarcinoma of the cardia Siewert I or II
* Existence of macroscopic peritoneal implants
* Patients with clinically significant ascites (\> 500 cc) even if cytology is negative for cancer cells, in the absence of other non-malignant causes of ascites
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01882933
Study Brief:
Protocol Section:
NCT01882933