OXALIPLATIN for Gastric adenocarcinoma

Inclusion criteria

• {"criterion_text":"- 18 < age ≤ 75 years old\n- Histologically evidenced resectable T3 or T4 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).\n- 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.\n- White blood cells > 3,500/mm3, neutrophils ≥ 1,500/mm3, platelets ≥ 100,000/mm3\n- Good renal functions, serum creatinine values being < 1.5 mg/dl and creatinine clearance > 60 ml/min\n- Performance Status ≤1, Karnofsky Index ≥ 70%\n- Serum bilirubin ≤ 2 mg/dl\n- Having given written informed consent prior to any procedure related to the study\n- Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research\n- Not under any administrative or legal supervision Specific to the study\n- Gastric adenocarcinoma and/or perforated gastric adenocarcinoma and/or Siewert III adenocarcinoma of the cardia"}

Exclusion criteria

• {"criterion_text":"- Prior malignant tumors with detectable signs of recurrence\n- Pregnancy or breastfeeding\n- Females of childbearing age potential or male subjects with partners of childbearing potential not using medically accepted contraceptive measures, as judged by the investigator\n- Contraindication to any drug contained in the chemotherapy regimen - Life threatening toxicity before surgery\n- Distant metastases (liver, lung. ovaries, etc)\n- Life threatening toxicity before surgery\n- Tumoral infiltration of the head or body of the pancreas\n- Patients presenting an adenocarcinoma of the cardia Siewert I or II\n- Existence of macroscopic peritoneal implants\n- 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\n- Gastric stump adenocarcinoma\n- Presence of comorbidities, notably serious chronic diseases or organ failure (ASA > 3)\n- Peripheral neuropathy grade of ≥ 3 (CTC-AE V4.0) (if appropriate)\n- Any subject in exclusion period of a previous study according to applicable regulations"}

Primary endpoints

• {"endpoint_text":"- Overall survival","definition_or_measurement_approach":"Overall survival at 5 years (5-year overall survival) as stated in the main objective (compare overall 5-year survival rates in the treated populations)."}

Secondary endpoints

• {"endpoint_text":"- Recurrence-free survivals (peritoneal recurrence, locoregional recurrence, metastatic recurrence, site of recurrence )\n- Treatment-related toxicity\n- Treatment-related mortality\n- Treatment related morbidity\n- Quality of life","definition_or_measurement_approach":"Recurrence-free survivals: measured from date of the surgery until the date of recurrence or end of follow-up (3-year and 5-year RFS specified). Treatment-related toxicity: assessed using Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Other endpoints: measurement approach not further specified in available data."}

France

Earliest CTIS Part Ii Submission Date

10-07-2024

Latest Decision Or Authorization Date

23-04-2025

Processing Time Days

287

Number Of Sites

11

Number Of Participants

367

Primary sponsor

Full Name

Hospices Civils De Lyon

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France